9/30/2020 Dr. Yogendra Show with Dr. Javitt - RLF-100 Update

9/30/2020 Dr. Yogendra Show with Dr. Javitt - RLF-100 Update: Video automatically transcribed by Sonix

9/30/2020 Dr. Yogendra Show with Dr. Javitt - RLF-100 Update: this mp4 video file was automatically transcribed by Sonix with the best speech-to-text algorithms. This transcript may contain errors.

Top of the Show

Dr Yogendra:
Ok, guys, stuck to Yo Yo show, I have a special guest, Dr. Javitt is back on, I think the last time I called you Dr. Jonathan Javitt, but that's your dad. So that's why...

Dr. Jonathan Javitt:
He's Normon.

Dr Yogendra:
Oh, OK. OK, so I got mixed up. OK. Well, Dr. Javitt's is on back on again. He's the CEO of NeuroRX. He's got a lot of exciting news the last couple of weeks and months. There's been a lot of interesting news and development from your company and RLF-100 and thank you again, Dr.

Dr Yogendra:
Javitt, for it for joining me and the rest of my followers and the community. I just wanted to jump right in. I know your time is so valuable.

Dr Yogendra:
The big question on everyone's mind and the discussion is the EUA. That was the news that came out a couple of days ago. Could you talk a little little bit about the way and the submission to the FDA?

Dr. Jonathan Javitt:
Sure. And. I can't tell you that I know what the FDA is going to do, but we told the FDA what our problem is, which is that they they very generously gave us the right to treat people all across the country with this drug under an expanded access protocol. That means that people who are too sick to be enrolled in our clinical trial, people with cancer, people with comorbidities that make them the wrong candidate for a clinical trial are able to be treated under our expanded access program. The problem is the expanded access program requires that hospitals set up an IRB (Institutional Review Board), that they basically go through a research pathway in order to be able to give this drug to patients.

Dr. Jonathan Javitt:
And over and over, we've had a heartbreaking incidence where families have told us we've done our best to supply drugs. But hospital administrators who were just up to their eyeballs in this pandemic can't really mobilize fast enough to hold in Nairobi meeting for one patient to get an investigational drug. So over and over again, despite everything we've tried to do to support families, patients have died before we were even able to get the drug to their hospital. So what we've asked the FDA to do is not expand the indication because we're going to wait for additional clinical trial data to come

Dr. Jonathan Javitt:
in before we ask the FDA to expand the indication. But we've asked the FDA to let us use the law. Congress passed under emergency use, which is much simpler administratively for hospitals than the law Congress passed under expanded access. Basically, a midsize hospital wouldn't have to have a meeting of its institutional review board for one patient to get our drug. So that was the reason we asked for the emergency use authorization.

Dr Yogendra:
Can you talk a little bit about because there's a big confusion know we're not prepared for pandemic medicine and exactly what you set up. The Jabat I Pahad personally went through this with patients, friends of mine, that doctor friends of mine that had patients and trying to get some of these emergency medications or these new therapeutics. It's a logistical nightmare. IRB, the infectious disease doctors, pharmacy, CMO, everyone's involved. And it's just a nightmare. I want to point out something that over the past couple of weeks, looking at your website after our initial discussion, I just want to just say how much I was impressed with on your website, how you streamlined all that information. And I think people should go in and take a look at the new website, because there's so many doctors, there's so many ICU doctors that have no idea about these medications.

Dr Yogendra:
And even if they were interested, the first question all of them ask me is, how do I get it? So it seems like you in trying to get this EUA (Emergency Use Authorization), you're trying to almost circumvent some of those issues that.

expanded access program

Dr. Jonathan Javitt:
So we're facing clinical medicine now, the expanded access program that Congress and the FDA set up works really well for an experimental cancer medicine, where you have days to weeks to decide that you want to use this investigational drug in a patient and to go through the procedures that are required. But unfortunately, people with critical covid-19 who are on ventilators, they have hours today's. And there's just not enough time to go through all of those procedures if you really want to do the best thing for the patient.

Dr Yogendra:
So if, let's say the FDA does grant an EUA or they accept the request, how does that change in terms of the clinicians on the ground getting the access to the medication?

Dr. Jonathan Javitt:
It would mean that a clinician can call the hospital pharmacy, order the medicine, the pharmacy will call our national supply chain, and the medicine will be there the next morning.

Dr Yogendra:
Wow that's that's, that's pretty that's pretty incredible. Now in terms of like what are we not to get into specifics, because he probably may not be able to talk about it. But in terms of overall, if you were just talking generalized terms, what are some of the things the FDA is looking for in when you're submitting? What is what sort of some of the information that they're looking at?

Dr. Jonathan Javitt:
Well, the law for an emergency use authorization is different from the law for drug approval. And drugs, according to the Food Drug and Cosmetic Act, can only be approved if they're proven to be safe and effective using adequately controlled trials. The standard for emergency use is a little bit different. The drug has to be shown to be safe and it may be effective. So we certainly have evidence that the drug may be effective, Dr. Yusuf in Texas, and the last time we talked, I hinted that he was going to be releasing data. That data is now out for people to see.

Dr. Jonathan Javitt:
Twenty one people who got this drug under the emergency and in the expanded access program, 19 of them survived and very few patients who were similarly situated in an intensive care unit being immunosuppressed from a transplant or from cancer or having a heart attack. Very few of those patients survive without the drug. So it's not a randomized controlled trial, but. It probably, in our view, meets the standard of maybe effect and of course, we need much better data from randomized prospective trials to be able to meet the standard of safe and effective.

Dr Yogendra:
So a question that's that's come up in some of the discussions I've had with with others is the EUA that would the FDA didn't say if there are specific or sort of group of patients. Does it have to be severe or critical, mild to moderate?

COMMENTS:
(EUA Application Specifics).

Dr. Jonathan Javitt:
About the application we filed? We asked the FDA only to let us treat the most severe patients, the same patients who already have permission to be treated under the expanded access program. So all we were asked to do is streamline the administrative issues about getting the drug to the patient. We've not asked the FDA to broaden the indication and we don't plan to ask the FDA to broaden the indication until we have more data to show.

Dr Yogendra:
And does that mean that the patients would it be like a could be used as a first option for those severe critical patients, or should they have tried some of the standard of care medications that are being used? Very clear that in our view, this drug should only be used when everything else has failed and the patient has no therapeutic alternatives. Because this is not an approved drug, this is still a drug that we're learning about. So if there are drugs that are approved that can help the patient, they should certainly be tried first.

Dr Yogendra:
And this is for it, just for clarification sake, this is for the I.V. version of RLF one hundred.

Dr. Jonathan Javitt:
Yes, this is for people who are in the ICU. And the reason they need to get the drug intravenously is that the lung is so full of inflammatory debris and fluid that if you give the drug by an inhaled form, it's not going to get through that mess to the lung cells that need to be treated.

Dr Yogendra:
And Dr. Javitt, one of the things I enjoyed speaking with you about is you have a very realistic perspective and not giving us fluff and cool. And that's why I think that was the first thing I got from our initial discussion. So, again, I appreciate the honesty and just really looking at things. As a clinician, I know you also have a role as a CEO of a company, but as a clinician, I really respect that. And thank you very much.

Dr. Jonathan Javitt:
Well, I try to come at it as a as a doctor first, and I remember my son, who's now doing his internship in medicine, came to me very worried when he was 11 years old. He had learned from from Marcia that I wasn't seeing patients at Georgetown Hospital anymore. I had taken a job as a senior vice president of the United Health Care. And I was helping them develop some of the first health care analytics programs, a company called Assortative.

Dr. Jonathan Javitt:
And we had developed the company and they bought it. And that's that's how I wound up moving from being a doctor every day to doing something different. And it came to be very worried and said, Daddy, aren't you a doctor anymore? And I said, well, of course I'm a doctor, too, but you're not going to the hospital. And I said, well, I've been given this chance to to work on a program that could help more people in a day. Then I'm able to to help in the year seeing patients one at a time.

Dr. Jonathan Javitt:
And as long as I have the opportunity, this is what I'm going to do. But I promise you that if I ever stop being able to to do that, I'm going to go back to seeing patients one at a time. So, yes, I have the privilege of being a CEO. I have the privilege of working with this incredible team and at NeuroRX. But I come at it from the perspective that every one of these people were treated with. Our drug is is a patient to whom I have responsibility.

Dr Yogendra:
And Dr. Javitt, again, thank you so much. I mean, that's just such a refreshing perspective and one of the main reasons I love I enjoy talking with you. It's just as from a doctor to doctor. It's like I have to sigh of relief, like, oh, we're just talking the basics of medicine and science. I want to shift gears just a little bit. You mentioned a little bit about the the trial and the phase three trials that are being conducted. I believe that the use of this heading that. Could you talk a little bit about the trial?

Dr. Jonathan Javitt:
Actually, the P.I. is Doctor Jayaweera at University of Miami School of Medicine. And Dr. Youssef is a principal investigator, as our principal investigator said, and other study sites. But he's all of them have been incredible, incredible colleagues to work with. And I'm very proud to have gotten to publish most recently with Dr. Youssef.

Dr Yogendra:
And in terms of those trials, there was some discussion about the interim data will be analyzed and also have these trials been fully enrolled? Could you give us a little update on that?

Dr. Jonathan Javitt:
Sure. And. I'm telling you this. You're the first to know, but a couple of minutes ago, we enrolled patient number one or two, randomised that person, which means that when that person hits twenty eight days, the data safety monitoring committee of the study is going to take the first efficacy. Look at the data. And they'll tell us one of four things they may tell us. The drug is dangerous and we should stop the trial. We don't think that's going to happen because we see every adverse event as it occurs and we haven't seen a lot of serious adverse events to either patients.

Dr. Jonathan Javitt:
What we don't know who's getting the drug and who's not, but we haven't seen that many adverse events in the whole trial. They may tell us that they see so little difference or no difference between the drug and the placebo group that the trial is futile and we should stop it because of that. They may tell us that the trial seems to be moving towards a meaningful answer and we should continue it, or they may tell us that the trial has already reached a definitive answer and we should declare victory and stop it. So those are the four things that somebody could tell us.

Dr Yogendra:
And that would be 28 days from from today, so probably end of October somewhere around that time.

Dr. Jonathan Javitt:
That's right.

Dr Yogendra:
OK, next question. If there is an approval in the US, let's say the EUA does get granted. Does it have another like a sort of snowball effect with what other countries might do, let's say Israel or England, a few countries? Could you shed some light into that?

Dr. Jonathan Javitt:
(ISREAL COMPASSIONATE CARE THROUGHOUT THE COUNTRY) Israel has already given its compassionate care protocol across the country, and we're in the process of working on how to serve that. It's important to recognize that emergency use authorization is not drug approval, it's a different law, EUA lasts for a year. It's designed only for the use of a drug in the face of a public health emergency. And yes, we're quite sure that other countries are watching carefully to see what happens, and it could very well lead to a broader adoption, should we find that that the drug works?

Dr Yogendra:
Does it usually is the decision of the FDA, is it usually influential in the decision making of other countries, or is it in your opinion, do you think it's sort of individual countries are making that determination?

Dr. Jonathan Javitt:
Well, it's always individual countries, but I think the FDA is far and away the most respected regulatory body in the world when it comes to the approval of new drugs. I think the Europeans have an extraordinary degree of respect for the rigor with which the FDA looks at new drugs. So the FDA's determinations are highly influential around the globe.

Dr Yogendra:
I think it was the last time we had a discussion, one of the more most impactful statements you made, not only to people that are following your drug, but even a lot of my physician friends who are know a lot of this is really brand new for a lot of the clinicians about the FDA and these emergency drugs. We just don't really come across them in our daily practice. And you said something about the FDA wants to approve medications. And I just thought that was so incredibly powerful. Just just to get some insight into really what the FDA is thinking and what this governing board or an agency that is they're meant to say no to everything.

Dr. Jonathan Javitt:
Well. Especially with congressional passage of the Twenty First Century Cures Act two years ago, FDA is really reinventing itself. You've got people leaving incredibly powerful jobs in industry and taking jobs as senior executives at FDA. The acting director of the Center for Drugs recently came from Pfizer. The head of the Office of New Drugs, I believe, came from I don't want to say the company, but I think it's Merck, but a major pharmaceutical company.

Dr. Jonathan Javitt:
So probably the most important thing about the Twenty First Century Cures Act is it gave the FDA the the personnel tools and the salary flexibility to attract some of the best and brightest pharmaceutical scientists in the country to come work there.And they're not going there to not approve drugs. There's nothing fun about turning down a drug. People are going there because they want to bring cures to patients.

Dr Yogendra:
And again, that's just it's just very insightful because we don't know a lot of this and you sort of become a big source for me in our discussions for for me to relay that information to a lot of my clinical friends. But I've looked at Dr. Javitt, you've got so much of experience and insight. So, again, thank you so much for your perspective on that. You know, one of the things we we've been talk a little bit about it with our loved one hundred is the potential for the other viruses and influenza, some of the other viruses that might be attaching to this to receptors. Could you shed a little bit of light into some of the future implications of the drug?

Dr. Jonathan Javitt:
(NIH AGREEMENT FOR Other Applications Announced a COOPERATIVE AGREEMENT WITH NIH - National Institute of Arthritis and Infectious Diseases for other implication RLF-100 - TESTING AGAINST FLU VIRUS) Well, and it's work that we are not equipped to do, but we've signed a cooperative agreement with NIH, specifically with the National Institute of Arthritis and Infectious Diseases. And. They are taking the drug. Into their virology laboratories. And testing it against the flu virus and other viruses that kill people by attacking the law. And who knows how it'll turn out?

Dr. Jonathan Javitt:
But if it turns out that there's a broader use for this peptide, that's going to be very exciting. And remember, we didn't invent this peptide. Sixty five million years of evolution or fifty seven hundred and eighty one years of a creator invented this peptide, depending on your belief system. But what we do know is that for as long as mammals have left the ocean and started breathing air instead of breathing water, the lungs became a very delicate organ. It's really nothing too delicate about the gills of a fish.

Dr. Jonathan Javitt:
And anybody who's ever tried to maintain the aquarium knows that the least little toxin will kill fish very quickly. But yet human beings are able to inhale a lot of smoke and recover from it. Occasionally they inhale acid, sometimes stomach acid, but sometimes people vomit and then acid and the lung recovers from it. And it turns out that this peptide is the way in which the lung recovers from all kinds of injuries, this peptides been around in evolution for so long and so successfully that mice and humans have

Dr. Jonathan Javitt:
exactly the same amino acid sequence in the vasoactive intestinal peptide. So often in evolution, as animals have become more sophisticated and at least some people think human beings are more sophisticated than mice. The the different hormones and peptides and the metabolism evolve and improve upon cells. But in fact, this this is one of the most closely conserved peptides. There is no variation in it's an amino acid sequence. So you start to think of it as sort of a perfect molecule. Nature can't do any better at VIP than it's already done.

People that survive COVID19 have 2 'x VIP in their lungs

Dr. Jonathan Javitt:
So we don't know probably one of the most interesting things we've seen is that when our colleagues in Brazil looked at people with critical covid, the people who lived, the people who got off the ventilator had twice the VIP, the natural level of VIP in their bloodstream as the people who died. So this peptide is doing something, and now we need to figure out all the different things that does.

Dr Yogendra:
And compare it to the RLF one hundred VIP or NeuroRx's VIP compared to some of the other companies making synthetic VIP what it is, can you just comment on the difference or are they the same?

Difference Between RLF-100 and PhaseBIO's (PHAS) Drug-PB-1046

Dr. Jonathan Javitt:
I only know about one other company, which is PhaseBio (Drug-PB-1046 Ticker PHAS) by, if you know of others. I'd love to look them up. And what they've got is a modified peptide that targets what's called the VPAC2 receptor. So it's not at all uncommon in nature for the same peptide hormone to have different functions in different parts of the body. And in this case, there are two kinds of receptors that bind to the VIP. You've got the VPAC1 receptor in the lung, you've got the VPAC2 receptor in the blood vessels. In the blood vessels It has a vaso dilating effect. In other words, it lets the blood vessels get bigger, blood pressure goes down. It also causes erections, which is why this drug is used for erectile dysfunction in some parts of the world. But that's a whole different receptor and the PhaseBio drug is optimized to increase the effect of the peptide against that receptor, whereas we're fairly certain that the effect on the lung that's beneficial in COVID is the VPAC1 receptor.So now if you know of other people with who are taking shots at improving on VIP, please, please show them.

Dr Yogendra:
Yeah, I think the big one is the PhaseBio, I think it's the PBH-1046, right. So, yeah, that was really the main one that I've come across. And I just didn't know if, you know, just because there's always we have this discussion about what are the differences. So that's very that's very interesting.

Dr. Jonathan Javitt:
And remember that that drug was developed with pulmonary hypertension in mind. They were looking for a way to make the arteries in the lung and the veins in the lung dilate and lower pulmonary blood pressure. A whole different effect.

Dr Yogendra:
Ok, I'm going to shift gears a little bit, Dr. Javitt, about you know, we can talk a little bit about the active covid, the severe critical. Now, if you're looking at that spectrum, you've got drugs that can potentially act as prophylaxis, preventative, and then medications for what everyone's calling the long haulers. Could you talk a little bit about where if there is a potential role for RLF-100 for for both those groups?

Dr. Jonathan Javitt:
Help me understand what a long hauler is..

Dr Yogendra:
Well, it's it's usually people that have recovered or quote unquote, they've recovered from covid, but they're having lingering symptoms. I mean, I just I've been sort of planted myself in a lot of these social media groups over the last couple of months just to get an idea. And I'm starting to realize this is going to be a big public health and a health care problem. The number of patients that are recovering from covid,

Dr. Jonathan Javitt:
But not really recovering.

Dr Yogendra:
Exactly. They're having some sort of these residual symptoms.

History of SARS-CoV-2 explained simply

Dr. Jonathan Javitt:
Let's start out with why this this virus hurt us? Because coronaviruses been around a long time. Lots of species of animals have actually known this virus for quite some time, Bats among others, And they don't get COVID. You don't walk into a cave full of bats and see them lying on the ground dead. So what's different here, what's different when this virus gets into humans than this virus in the animal reservoirs where or at least viruses like this,

Dr. Jonathan Javitt:
In the animal reservoirs where it's been relatively harmless. And the difference is the virus binds to what's called the ACE 2 receptor and the alveolar type two cell that's critical to the function of the lung has ACE 2 receptors on its surface. So the virus goes inside that cell and causes all kinds of trouble. The first thing it does is it shuts down the production of surfactant. And if you go back to evolution and say, well, how did we manage to get out of the sea and into the land, especially want to breathe air?

Dr. Jonathan Javitt:
Well, air is full of a toxic gas called oxygen. So how do you keep that oxygen from just incinerating the cells of the lung? Well, you have to keep those cells wet. And you can't just put water on them because the water will run right off, just like if you put water on a piece of glass, the water beeds up and runs off, but put the tiniest drop of dish soap on that piece of glass and all of a sudden the water spreads all the way across and stays there in a thin film.

Dr. Jonathan Javitt:
And that's what's affecting dust in your lungs, keeps the lung coated with a very thin layer of water, and that's what lets the oxygen go across, the lung will be shut down. The surfactant, you can't oxygenate your blood. And that's the beginning of COVID 19. So if we can preserve those type two cells early in the disease, then maybe there's a chance we can really make an impact on the disease.

Dr. Jonathan Javitt:
And we've already heard rumors that a very, very good doctors in Germany have used this drug on a limited number of patients on an inhaled basis. And in fact, those patients are back home. So it may well be that this drug, and that's why we filed the inhaled use protocol, which we're about to start administering. This drug may well work in early disease.

Dr. Jonathan Javitt:
It might even work in those people with what we call the COVID prodrome. People who don't yet have lung disease, but they've lost their seat, their sense of smell and taste. And we know the virus is up in their nose. It has gone down to their lungs yet this drug could even work as a nose spray. But we've started out with the most acute patients, with the patients who really had no alternative, because when we started this program, we knew very little about this drug. We had 15 year old data that Dr.

Dr. Jonathan Javitt:
Syeed had accumulated while he was still alive. The drug hadn't been used in human beings in 10 years. And here we are going to the FDA saying, well, it's not our drug. We never, never did anything with this before. Nobody's done anything with it in 10 years. And we want you to take a risk and let us give it to people. So we start with the people who had no other choice. But now, as we're getting more comfortable with it, as we're seeing that there are not adverse events, as we're starting to see a hint that the drug may be efficacious.

Dr. Jonathan Javitt:
Or at least may be effective, certainly w ouldn't begin to say it is effective. Now it's time to think about can we use it earlier in the disease? And by the same token, it may be that as we try to help people's long recover, because, as you pointed out, it can take months, maybe years. For the lung to really recover from the incredible insult the virus causes, maybe this drug does have a role in long term recovery.

Dr Yogendra:
Yes, it's looking at some of the data from from SARS, sort of the only long term complication or permanent complication with the respiratory and the pulmonary fibrosis, most of the ones seem to be if you are looking at the two thousand and three SARS epidemic or infection, It really, all the data suggests that after 12 to 18 months, most of these, quote unquote, long Hauler symptoms result except the respiratory. So just trying to look at the mechanism of action and trying to see the potential role, just brainstorming.

Dr. Jonathan Javitt:
We've got some very intriguing data from one. Biogen was developing this drug in the two thousands on pulmonary fibrosis. They didn't hit a statistically significant endpoint in what we call idiopathic pulmonary fibrosis. These are the people whose lungs scar down and without a lung transplant, they die. But that's a very slowly progress to see if the question is, can we? Help prevent the pulmonary fibrosis that results from exposure to a SARS virus. The answer is maybe.

Dr Yogendra:
Yeah, it's it's just got so many interesting implications, especially the safety, the not only the I.V. version, but also the nebulized version that that your team is working and developing. Dr. Javitt, I want to ask you a question about sort of the immunology. Because the last time you were on, we were discussing about those Nine, I believe the twenty one patients that you were studying, that the interleukin six levels came down. So maybe some of the other immunological markers. Can you talk a little bit about since the time we've discussed you first came on, sort of have you were able to understand the immunology a little bit better and sort of how RLF-100 is working on sort of the immune system?

Dr. Jonathan Javitt:
I'd like to say the answer is yes, and the truth is we're so busy in clinical trials and we're not a basic science company, I'm sure one of the sad things about this drug is around about two thousand. If you weren't doing genomics, you weren't getting your grants funded. So the kind of cell biology and cell physiology that taught us what we mostly know about VIP stopped being funded by the NIH 20 years ago. It's kind of old fashioned science. And I sure hope that people go back into the laboratory and decide that we need to learn more about this.

Dr. Jonathan Javitt:
But that's the kind of science that takes a long time to do. And if you don't have the grant funding around to attract the best and brightest PhDs, it just won't get the.

Dr Yogendra:
The reason I bring that up, Dr. Javitt, is whenever someone there's a new theory or hypothesis that's out there and the media picks up on it, suddenly everyone wants to see how their respective drug, their supporting connects to it. A few weeks ago, Bradykinin in theory. I think that's a lot of discussion about the rantis system, Interleukin six playing a role. So everyone wants to see what's that relation? And like you said, it's obviously takes a lot more, takes a lot of funding and time and effort to really examine that.

Dr. Jonathan Javitt:
Yes.

Dr Yogendra:
So shifting gears, a lot of questions about this sort of the marketing and the partnerships. I woke up this morning to see the announcement that your team had an announcement with the manufacturing deal with Nephron Pharmaceuticals.

Dr. Jonathan Javitt:
Correct.

Dr. Jonathan Javitt:
Could you talk a little bit about sort of the scaling up, the marketing, some of the partnerships our is going to be is involved with right now?

COMMENTS:
(SCALING, MANUFACTURING, CONTRACTS AND LIMITATIONS, Logistics company contract signed and 4 Million Doses of RLF-100 being made by BACHEM America).

Dr. Jonathan Javitt:
So. With NAFTA's blessing, we kind of broke all the rules in getting this drug into the clinic, the March 1st. This drug is in 70 file boxes and May 15th, we're treating the first patient. And we were able to do that because FDA gave us permission to work with what's called a formulating pharmacy. A an organization that is able to licensed to make drugs that are not commercially available for patients who need them. Really wonderful organization in California, MediSource. But now we need to focus on, well, how do we go from making a few doses of a drug for our clinical trials and our expanded access program to potentially making a million doses of drug? And that, of course, requires alliance with manufacturers who are able to do that. And Nephron is the largest manufacturer of sterile, inhaled drug in the United States.

Dr. Jonathan Javitt:
Similarly, we need a way to get the drug to people and we don't have nearly enough employees to carry it to the post office. So we've signed a relationship with the largest third party logistics operation in the United States because they're fairly large. We're waiting for permission to say exactly who they are, but people can guess. And so that we now know we'll be able to get drug to somebody overnight. And of course, in order to make drug, we need the raw ingredients and therefore we've set up a relationship with BACHEM America to secure to ask them to make enough peptide for us, 4 million doses of drugs.

Dr Yogendra:
And what some of these partnerships also allow you to expand and scale up in Europe and the other parts of the world, or is it just targeting. The United States?

Dr. Jonathan Javitt:
Well, these are partnerships that are US focused, flood relief therapeutics is in the process of putting similar partnerships in place that will serve the E.U., the organization we've contracted with to be able to get drug to anybody in the United States overnight, doesn't do that in Europe. Other people do that in Europe. Manufacturing, there may be some overlap or Relief, may choose local manufacturing partners. And of course, BACHEM of Americas is owned by a Swiss company, BACHEM AG So the same ingredients can be manufactured for the European marketplace.

Dr Yogendra:
And I try to steer away from some of these pricing questions. I would really like to keep it on the medicine and clinical. But big question that oftentimes comes up is sort of the pricing of RLF-100. If it does get approved, what will be the cost?

Dr. Jonathan Javitt:
You know, we don't really know, but we do know that we don't intend to have the cost be a barrier to anybody who needs the drug. Clearly, people have taken substantial financial risk for this drug to to get to where it's gotten. And if investors can't get rewarded for the risk they take, then there won't be investors in the pharmaceutical industry. At the same time, if drugs are too expensive, then they won't get used.

Dr Yogendra:
And just along those line, the last questions that are relating to sort of the stock and price is a lot of people asking questions about plans for Nasdaq or any of the up listing. Could you comment on that?

Dr. Jonathan Javitt:
It wouldn't be proper for me to comment on that. When you say the uplisting?

Dr Yogendra:
Are there plans for to be listed on some of these big stock exchanges.

Dr. Jonathan Javitt:
For NeuroRX to be listed?

Dr. Jonathan Javitt:
Because, Relief of course, it's a publicly traded company.

Dr Yogendra:
Right. I guess for for both.

Dr. Jonathan Javitt:
Well, Relief Therapeutics is traded on the Swiss stock exchange, and they were recently up listed to the OTCQB in the United States. And given the the investor appetite for the stock, really, stock tends to get uplifted based on its trading volume. So I'm confident that as long as people continue to have an appetite for that stuff, it will continue to be uplifted. In terms of NeuroRX, we certainly promise the people who took risks on us when they invested in us in twenty fifteen and along the way since that at some point public.

Dr. Jonathan Javitt:
(DOGS BARKING) I have an appreciative audience.

Dr. Jonathan Javitt:
And and at some point confident that we will hopefully sooner rather than later.

Dr Yogendra:
And Dr. Javitt, just for the record, I do not own shares, I know that might disappoint you, but I try to be as unbiased and I really, really appreciate your work and the drug. So although it's tempting at times because I really believe in you and the science you've discussed. But just for the record, I'll throw that out there. I just want to go back to just a final questions about the EUA in terms of a timeline. I know it's I'm putting you on the spot. Very hard to to say when, how does that work? Is the FDA give you a call? Did they send an email? And what is the expected? How long does an average and like I said, this is this is.

Dr. Jonathan Javitt:
Remember, the emergency use authorization is a process that the FDA has not used a lot. So the answer is we don't know. We've heard that they tried to respond to these requests in 30 to 60 days, but the response might be a request for more data.

Dr Yogendra:
And final question, Dr. Javitt, the a lot of questions about I've been getting about the peer review on the submitted papers, could you shed some light into that progress?

COMMENTS:
(PEER REVIEWING OF PREPRINTS).

Dr. Jonathan Javitt:
Those papers are under peer review having. Rumor has it that somewhere around the top one percent of published scientists in the US, if you look on Google Scholar. Having been involved in the publication of lots of scientific papers, the wheels of science grind slowly. You know, we sent them, we've gotten comments from the peer reviewers. We've responded to some of them. We have other comments to respond to sooner or later. I'm confident that this stuff will show up in the journals.

Dr. Jonathan Javitt:
In the meantime, people can read the science on, SSRM.com and draw their own conclusions. There's really nothing, I have I've been a reviewer. I've been an editor on some well-known journals The fact that two peer reviewers who were kind of randomly picked up by an editor like a paper or don't like a paper doesn't necessarily mean it's a good paper or not a good paper. It just means that that's what those two people thought.

Dr Yogendra:
And Dr. Javitt, I just want to say your insight into all of this is, well, much appreciated. I learned so much about the FDA, the review process, these papers that I didn't really learn in medical school or residency or in private practice. So one of the things people always ask me is why do you believe in this drug and this company? And a lot of times it goes back to such a great leader. I talked about that on social media. Your fund of knowledge or understanding is so just I appreciate I really appreciate your science to your insight and your expertise.

Dr. Jonathan Javitt:
Thank you.

Dr Yogendra:
Thank you for your time. But I'm just going to say the final word. I'm going to give it to you. But what do you say to the physicians or patients? What is some of the Take-Home message, too, that they can look forward to in the future and something we should all be excited about?

Dr. Jonathan Javitt:
Well, I think we're going to learn an awful lot. Twenty eight days from now. And I can't tell you what we're going to learn. I hope that what we learn is consistent with what we've already seen in the twenty one recent study. We are encouraged by the DSMB's ruling in July identifying that they didn't see a safety problem, they didn't see a problem with futility. So we're all going to learn a lot in twenty eight days. Yeah, no, that's really exciting and Dr. Javitt, thank you so much for your time.

Dr Yogendra:
I know you've just got a jam packed schedule, and I think it's just really important that the medical community, physicians, patients know about this. Your last interview was so powerful because I was able to talk. There's so many patients have reached out to me, families from all over the world. And I was able to direct them to our discussion, to your website. And I just want everyone to know that your website is hands down, at least for the from the smaller biotech companies. Dr. Javitt, you've muted it yourself.

Dr. Jonathan Javitt:
Sorry, but I was actually asking my dog to mute himself. OK, I was going to say the website is really, really incredible.

Dr Yogendra:
You guys have done such an amazing job that's so streamlined. It's I'll post a link to it so that people that haven't gone to it can see how incredibly powerful those patients told me. Oh, and doctors told me we learned so much about it just from going to that website, just about overall, that process. So thank you so much, Dr. Javitt At your leadership. Your insight has been awesome. Thank you.

Dr. Jonathan Javitt:
You're wonderful. Thank you for doing what you do. It's really a pleasure to come visit with you.

Dr Yogendra:
Absolutely. And hopefully in a couple of weeks and months, you'll have some even bigger news. And we can really talk to science and medicine again.

Dr. Jonathan Javitt:
Thank you.

Dr Yogendra:
Thank you, Dr.Javitt.

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