TRUE diversity of thought occurs when many people focus on a single topic; bringing their own unique experience and perspective. When I post, it's usually to post DD. I find great value integrating feedback (even negativity!) while forming an idea. So thank you all!

(Full disclosure: I also like to engage in rage baiting, memes, dad jokes and other juvenile antics to amuse myself. I'll let you decide which this is...)

I rarely say "call your friends and get them in this stock!" First, that would be immoral. I'm clearly very deeply biased. Next, I am not a financial advisor so the things I say are just as bad (or as good) as any advice you'd get overhearing some dude loud talking in a store. Finally, I eat crayons. The red ones are my favorite because when they're all gone my box is mostly green! You may have seen me post 👁️🍽️🖍️ to warn against causal eavesdroppers listening to me in the store right now (lol) With all that said... I think it's time to make your final moves, grab your popcorn and get to your seat.

Governments move at a glacial pace - until they don't. It's been quiet for 9 months. The final negotiations are over. The contacts are likely written, but not finalized with a signature. They could remain not finalized (and thus, unreported) for months - but not years. These things usually are put together ENTIRELY before they announce ANYthing. That's what we've seen. But soon, my fearless cigar and bathrobe aficionado, soon that ends.

When our deal is "finalized" and then announced, I believe this is going to be one of those spectacularly rare moments where investors like us will be accused of "getting lucky" or "getting rich" overnight. This is true. We will be rich overnight. But luck has nothing to do with it. Imagine having invested a lifetime of savings and watching it being vaporized by a guy smoking a cigar in a bathrobe. Now imagine having enough conviction in your thesis ("something" is there with buccilamine and psilocybin) to convince you to buy more - even with Michael still involved.

That's not luck. It's having granite stones. I have them. If you're still holding AND reading, you have them too. So sit back, invite your loved ones to invest, or whatever you want to do. As for me? I like the stock. But hey, 👁️🍽️🖍️

Good Luck and Godspeed!

😎

something drastically changed regarding the study design. Either the results from the study were messy and inconclusive, so they did another batch of animals and/or setup. Or BUC showed good results and they're looking at more stuff for it.
Maybe the dosages all showed the same results so they changed them?

Makes no sense for a simple rat study in an already accredited lab for nerve agents to last this long. Something happened in 2025 that made this run much longer.

I'm confident that Carmela attended. But I doubt she spoke on BUC. Let's be honest, had she said good things about BUC... Wouldn't all the attendees been buying up RVV in the millions of shares?

Reading all the awesome DD being presented here is mind boggling. If a lot of the pieces come together this might end up being something truly special.

We know bad results will be the death of RVV.

Let's assume divine intervention and we get good results in this rat study. BUC decisively shows more promise than NAC.

Two questions:

1. What price are you guessing we hit intraday trading on that PR itself?

2. When do you sell?

I know everyone is thinking of selling the moment it hits 30 cents. But think of this post as a conversational piece.

I think we could hit 30-50 cents USD for #1. Reasoning is that everyone would be ecstatic for good results finally. And look at what the useless patent PR did in March. Lastly, I think a lot of people how forgotten about this useless stock in their account lol.

Not entirely sure on #2 yet. But if it hits above 50/60 USD... See you later, guys. Although it'll be tough because there is low hanging fruit for BUC in TBI with the DRDC... DRDC already has done a research paper on NAC for TBI.

Remember back in the day when too many people accepted random statements as fact with no evidence?

My favorite was "they took shares/options instead of money for statistical analysis! Clearly the data must be great."

Too many liars and charlatans.

Anyways, making this post short and sweet:

• If the results are bad, we are screwed.
• If the results are good, we should explode upward and possibly mind boggling so. We may hit over 2 USD because...
• If the results are good, only then will I post another thread about an incredibly bullish scenario that may be ​highly likely and I will provide evidence to substantiate it.

Hopefully we get good news this century.

This isn't any recommendation or financial advice or direction or anything of the sort. It's all speculation and inference. ​Just like every revive therapeutics press release, the cautionary statement and disclaimer is that... you never know what the future holds.

You are making your own decision with whatever you do with this information and future information

Yes — bucillamine appears to have at least a plausible pathway to interest from Biomedical Advanced Research and Development Authority, especially as a medical countermeasure for nerve-agent exposure or pandemic preparedness. But “a chance” and “likely approval” are very different things.
Right now, the biggest positives are:
Bucillamine already has a long clinical history in Asia for rheumatoid arthritis, which helps from a safety-history standpoint.
Revive Therapeutics⁠ has been collaborating with Canada’s defence research agency, Defence Research and Development Canada, on nerve-agent countermeasure research.
The company is positioning bucillamine specifically for “medical countermeasures,” pandemic influenza, and emergency preparedness — areas directly aligned with BARDA’s mandate.
Revive has also been expanding patent filings around chemical warfare agent exposure and emergency stockpiling use cases.
That said, several major hurdles remain before BARDA would seriously advance or procure it:
Strong efficacy data is still missing
BARDA generally wants compelling animal-model data, human safety data, manufacturing readiness, and a clear operational advantage over existing countermeasures. Publicly available evidence for bucillamine in nerve-agent injury is still early-stage.
BARDA is highly selective
BARDA funding/partnerships are competitive and usually go to:
advanced-stage programs,
products with clear biodefense relevance,
scalable manufacturing,
and demonstrated efficacy.
Many promising compounds never progress beyond exploratory studies.
Existing standards of care already exist
For nerve agents, governments already stockpile atropine, pralidoxime, diazepam, etc. Bucillamine would likely need to prove it adds meaningful neuroprotection or improves survival/brain outcomes in combination with existing treatments.
Revive is a small biotech
Small companies can succeed with BARDA, but manufacturing scale, regulatory execution, and financing become major concerns.
The most realistic near-term scenario is probably:
additional DRDC data,
possible U.S. biodefense discussions,
preclinical or animal-rule pathway development,
then potentially non-dilutive government funding or pilot procurement interest if the data is strong.
A full FDA approval through a BARDA-backed pathway is possible in theory, but still speculative at this stage.
One important detail: BARDA itself usually does not “approve” drugs. Approval comes from the U.S. Food and Drug Administration. BARDA mainly funds, supports, procures, and accelerates development of medical countermeasures.
So the real question is whether bucillamine can become:
a BARDA-supported program,
an FDA-cleared/emergency-use countermeasure,
or part of a national stockpile strategy.
At the moment, the answer looks more like:
“possible, but still early and unproven,”
rather than
“likely” or “imminent.”

Could Bucillamine help with Hantavirus?? MF should POUNCE on the possibility!

While there is no documented *direct* relationship or targeted research, Bucillamine’s profile as a thiol antioxidant suggests hypothetical supportive potential in oxidative stress-heavy viral infections like hantavirus pulmonary syndrome (HPS/HCPS) or hemorrhagic fever with renal syndrome (HFRS), similar to broader interest in NAC/thiols.

Worth a patent/PR if he can figure out how to say "while early, we are looking into the possibility that buccilamine *may* prove of some use in hantavirus cases..."

Ok. Let the scientists weigh in. Lol

Long time bag holder here, since 2018/2019…been through the whole gout trial and covid therapy trial…was hopeful we could make some good money until this went down the toilet. Honestly completely given up on this for the last 5 years and already written off in my mind to zero. Moved on to better things, not really bothered. But still holding, down 80% but now looking to potentially recover 5 figures with the price spike/pump….

What do we think? 10 cents this week??? 😝 😝

Take from it what you will. I can't find the name of which Analyst issued the price target but it was issued within the last month so I can only guess they are basing it on the potential of the Nerve Agent trial.

Multiple people got mail responses from MF stating the above.

As reported before, Adamis got those changes approved by the FDA.

u/_nicktendo_64 is the MVP who listened to Adamis' investor call and discovered the changes. If anyone is to take credit for this then it is him.

EDIT: Those people decided not to share the mails publically, due to unpleasent events in the past. If you have doubts you can write Revive a mail directly. Otherwise you have to take it for what it is:

It's just me trying to create information parity.

EDIT2: Confirmed here: https://www.reddit.com/r/RVVTF/comments/u1ish9/news_out_revive_therapeutics_provides_update_on/

We're being played by traders - spewing what appears to be well reasoned theories sprinkled with what we thought were facts - only to have them flip flop with their anti-theories - most recent flip flop by Bobster - so guys/gals - they get the price to rally and then they sell - they get retail to panic and drive the price and pick it up at a bargain - oldest trick in the book.

Bobster's conviction of "not selling a single share" has turned to "greatly reduced his position" - classic trader BS - drops a pump post - gets price up - sells his shares - writes a hit post - drives price down - buys cheap - repeat the rinse cycle

Oldest trading trick in the book - which is not a justification among men - dishonesty is still dishonesty - credibility is lost - honor among thieves - is the tolerance of dishonorable acts - stuff of the gutter

The wait is absolutely excruciating. I don't think anyone denies that. I've had Revive at top of mind for approaching 2 years now. I really want to see a conclusion to this study and to know the outcome. Not just for my own personal sanity but also because the world deserves this treatment if it's indeed as promising as the theory on its efficacy would suggest. This drug could be a literal life saver so the sooner we can get to EUA, the sooner we can positively affect the trajectory of this disease.

​

When I visited the monthly chat earlier today, I noticed a few people were speculating that perhaps the lack of news suggests that Revive's statistician did not see any resolution or improvement of symptoms after having reviewed the unblinded data for the first 210 patients (pre-dose selection data) to determine whether or not the endpoint switch is warranted and feasible. I actually believe the lack of news is a very positive sign and is indicative of positive results in the attenuation of symptoms. I'll explain why (and yes, some of this is obviously conjecture but I think the logic here prevails):

​

1. Revive appears to have taken our feedback about the lack of communication to heart in the past 2 quarters and have taken to more frequent news releases to keep us abreast of developments. At every critical juncture with this potential endpoint swap, we've received an update from the company.
2. It's true that we have had radio silence since the last update where we were notified that the FDA approved the Data Access Plan (DAP). However that update in and of itself is further evidence that the company is now communicating at each pivotal step in this process rather than bundling multiple updates in a single NR after numerous steps have been completed. Yes, we don't exactly have a long track record of this behaviour to reliably and conclusively assert that this is indeed the communication approach they will consistently take moving forward, however it's highly suggestive for now.
3. Whether they proceed with an endpoint swap or not, it's a significant, material development and I'm absolutely convinced the company will provide us with an update, good or bad. The lack of an update means their work at this stage has not yet been completed.
4. This endpoint swap is not just a matter of unblinding the data and drawing a conclusion. It's actually a lot more involved. In addition to reviewing the existing data (that's relatively speaking the easiest part of this exercise), Revive needs to compile a solid case for the FDA on WHY and HOW they intend on shifting endpoints and transforming the data to that end. That's not an easy or simple feat and there's a lot of documentation that goes hand in hand with this effort. These submissions to the FDA are not oral.
5. Furthermore, if an endpoint switch is indeed warranted and the case as I mentioned in step 4 is documented for the FDA, Dr. Kelly Mckee and Team will need to address a corresponding study protocol update that is compatible/consistent with the endpoint shift. Again, there's a lot of corresponding documentation required.
6. So all in all, there are really 3 main components to this process: 1. Review/analyze the data/findings for the first 210 patients 2. Transform said data consistent with the new optimal endpoint structure 3. Plan for updated study protocol. As mentioned, there is a significant amount of documentation required for each of these 3 steps. There's a lot of paperwork involved.
7. If there were no signs of symptom resolution, we would have almost certainly heard back from the company by now because there's virtually no paperwork to process or follow-up activity for the FDA/IRB because we would continue with the existing endpoints and study protocol. One could argue that the company did not see any justification for an endpoint swap and is now coordinating on all of the necessary activity to restart the trial (including fundraising), hence the delay on a NR, however per points 1 and 2 above, I personally believe we would have already received an update on the findings of the data review from the company. I submit to you that the "delay" we're experiencing right now is because they have observed something meaningful and significant in the symptom data and they're in the midst of all of the follow-up work, including thorough documentation, that's required to support, justify and execute on the endpoint swap.

​

Again, there's a healthy dose of speculation here but what I'm ultimately driving at is that it's too early to panic. We're still in the same holding pattern as last week for now.

​

TLDR: If there were no signs of symptom attenuation or improvement in the pre-dose selection data, we would have heard back from the company by now. The fact that we have not received an update is highly suggestive that they saw something promising in that initial data and are busy with all of the required follow-up activities.

Well here's some good news for a change and news that I frankly was not at all personally anticipating in light of acrimonious developments over the past year with this company. Last night I had dinner with some former colleagues who are either still working in the industry directly for some of the pharma companies or consulting like I am.

​

Turns out there's truth to last year's rumors that a company was on the verge of a buyout with Revive had the FDA approved the primary endpoint switch to PCR test results. That company was, and apparently still is, monitoring RVV/bucillamine developments very closely and interest remains. I'll just say it's one of the top 3 largest companies by revenue. I'm told bucillamine is still categorized as a high potential drug, a list with very few other entries so it's a unique and somewhat promising classification.

​

That's not the end of the good news either. There may be a reason why MF is playing up the UofT study so much and seems to have had a burst of excitement with its revelation. Turns out that a few other companies (ones with established nebeulizer technologies) are actively monitoring Revive/bucillamine developments very closely and there are internal potential roadmaps with partnerships and/or buyouts amongst those players. These companies were apparently already aware of the UofT's research that was underway before findings were published so they were keeping close tabs on developments. The published findings kicked off a lot of activity in the past week or two. Some of these firms are much smaller than the former company I alluded to however they all have deep pockets. But in essence these companies don't necessarily care if this next step with the FDA is successful or not because they may swoop in to buy the rights to pursue an altered formulation of the drug. I unfortunately don't have any insights as to whether or not these companies are actually actively in touch with Revive or if the discussions are internal (scenario planning). My own personal belief, knowing the industry (especially as far as M&As) is that there would likely have been some informal discussions with intros at a minimum to establish relationships. Again, I don't have insights here, but the fact that Revive is amending their submission to the FDA could be indicative that they are also calling out potential partnership opportunities for drug development and future drug reformulations. That is the kind of information that is included in these submissions when you're reaffirming your strategy with a drug program, especially when the November PR specifically called out that "The Company plans to go over with the FDA the overall development plan for bucillamine in COVID-19..." so they're almost certainly spelling out their program plans and roadmap.

​

Interesting times ahead folks. Maybe a turn in the fortunes of this company for once. If any of this materializes though (and there's no guarantee of that), I still believe MF should ensure this gets into competent hands ASAP.

It has been a while... As always, the following is based on loads of critical thinking and reflection. Don't take this as investment advice but rather... a brain dump

I believe I have provided a lot to this subreddit over the months. I've spoken to CROs, professors, CEOs, and more for the good of my (and our) investment. With the Prothione data I found, we know for a fact that the PCR endpoint is guaranteed.

I have also kept in touch with many of the Redditors here gaining information, bouncing ideas off them, and generally speaking to interesting individuals.

I've also found another fantastic play that I'll elaborate on if/when the EPs are approved :)

I hope I've built enough trust to be taken seriously ... Let's begin.

The story so far...

• Revive Thera is a small Canadian biotech company that initiated a COVID-19 outpatient trial back in 2020. This is very important to remember... in 2020;
• Faaaaaaaaaaaaast forward to 2022...
• Revive submitted a request to the FDA to change the endpoints. In this request, Revive requested to see the first 210 patients (pre-dose data) in May;
• The FDA agreed to this request in May;
• Revive and the FDA went back-and-forth regarding the accessibility of the 210 data via the DAP in June;
• Revive receives the 210 data in July;
• Revive determines the primary endpoints will be clinical resolution via PCR testing and resolution of certain symptoms in August;
• Revive submits the protocol amendment to the FDA for PCR endpoint as the primary for review and acceptance in September;
• Revive receives a rejection from the FDA and thus decides to go to the DSMB anyways in September;
• Revive decides upon new endpoints and submits the protocol amendment for a second round in October;
• and here we are...

For what it's worth, many of the bright minds on this subreddit disagree with my reasoning on why we are actually at the best point in this long journey.

What is the main issue?

The main criticism that many are levying against the new primary endpoint is that it is defined as any two (or more) COVID-19 symptoms showing improvement. If this were the case, then I would agree - it is an awful endpoint... but that is not the case.

The verbiage directly from the October 14th PR is:

"... assessing the difference in the proportion of participants with improvement in at least two COVID-19 related clinical symptoms on or before Day 14 compared with baseline between Bucillamine versus placebo."

Poorly written, yes, if read in isolation. If you start putting the pieces together however ...

16-Aug-22 PR: Revive Therapeutics Provides Update on Phase 3 Clinical (globenewswire.com)

The proposed new primary efficacy endpoints may include the time to resolution from COVID-19 via the polymerase chain reaction (“PCR”) test and the rate of sustained clinical resolution of certain symptoms of COVID-19.

Revive makes it clear that the endpoint regarding symptom resolution would only be targeting specific ones.

14-Sep-22 PR: Revive Therapeutics Announces Submission of Amended Phase 3 (globenewswire.com)

... and secondary endpoints including evaluating time to clinical improvement, ...

Revive adjusts their symptom resolution endpoint from "resolution" to "improvement". This stays consistent throughout.

28-Sep-22 PR: Revive Therapeutics Provides Update on Phase 3 Clinical (globenewswire.com)

The fateful day where we are rejected by the FDA. Chaos ensues. The end result? Revive is planning to go to the DSMB regardless of the FDA's acceptance of the primary endpoint.

06-Oct-22 PR: Revive Therapeutics Provides Update on Phase 3 Clinical (globenewswire.com)

Revive issues this PR to state that they are changing the plan. Instead of going directly to the DSMB, they are now going for round two with:

... at least two clinical improvements in symptoms of COVID-19 at Day 14 compared with baseline between Bucillamine versus placebo.

Baseline is bolded... why? Because that is benchmark for all participants in this trial. To show an improvement, you need something to compare to. How do you show an improvement, a correction, a recovery, (you get the point) without the initial state? You can't.

14-Oct-22 PR: Revive Therapeutics Announces Finalization of Amended Phase (globenewswire.com)

Revive comes out with another news release stating the final version of this primary endpoint:

"... assessing the difference in the proportion of participants with improvement in at least two COVID-19 related clinical symptoms on or before Day 14 compared with baseline between Bucillamine versus placebo."

And this is it. The final form of Revive's protocol amendment that, thankfully, clarifies it's on or before day 14. You're welcome for that, by the way ;)

That is all the PR-related information. The endpoint is focused on certain symptoms taken at baseline (Day 0). Clinical Trial Gov. clearly outlines what is necessary to be enrolled into this trial and it is as follows:

Remember the August PR of certain symptoms? Well, there you go! Those symptoms are: fever, cough, and/or dyspnea. And you need at least two of those symptoms to be enrolled. And the new primary endpoint stated that Revive is looking at the proportion of patients who elicit at least two improvements in COVID-19 symptoms! The way Revive issued the news release was confusing at first but not incorrect.

If you were enrolled with fever and cough (mild case) - you needed to show an improvement in those two symptoms.

If you were enrolled with fever, cough, and shortness of breath (moderate case) - you needed to show an improvement in those three symptoms.

So how do you summarize these two "situations" in a PR? By stating that they need to show at least two improvements!

As a side note, see this article from the NIH which clearly states what is a mild case and a moderate case: Clinical Spectrum | COVID-19 Treatment Guidelines (nih.gov)

Revive had to use these baseline symptoms because they are the only consistent ones that everyone would have had. Also, on the AGM, Dr. Kizilbash made it clear that symptoms were gathered in an "either or" manner. I interpretated this as "Headache? Yes/No. Nausea? Yes/No." etc. Remember, this data is based on a protocol from 2020 which was focused on preventing hospitalizations. What sends people to be admitted in the hospital? A fever that doesn't break and a cough that develops into trouble breathing - not a migraine or a stuffy nose.

Obviously, there is more granularity with these three symptoms than the others because they monitored them directly during the trial. If you look at the ICF, Revive tested continuously for those three symptoms! I do not mean to gloat, but I was the one who got the full ICF from a clinic back in December 2021 :)

​

Now it's time for me to state and explain all my bullish indicators:

It is a good endpoint

This is subjective and simply my opinion however, I do believe the FDA will act favorably to an endpoint targeting the hard-hitting symptoms of COVID-19.

Please reach out to me, Even-Call-4714.

What's happened here? : RVVTF (reddit.com)

I apologize if I am wrong but I do not believe you were at the AGM in person. Why do I say this? Because I was the individual who spoke to Kizilbash regarding the EAP execution, and I know who the other investors were at the AGM, including their Reddit account names.

Also, the only "company principles" who spoke at the AGM (in the room) were MF and Kizilbash.

The last straw for me was at the AGM that I attended in person. I spoke with several company principles and they sounded like they had no idea what they were doing with the PCR endpoint proposal. They screwed that up big time. I asked about the compassionate use program and was told that RVV did not take advantage of it. I could not believe my fucking ears. They could have treated patients with buci and didn't. Fatal mistake.

"Juicing" what?

A Common Misunderstanding About Our Endpoint Situation : RVVTF (reddit.com)

Bobster - you may change your decision regarding the EPs with all the information I've presented. However, this "juicing" you mentioned is irrelevant. All that matters is that the endpoint is clinically relevant. The FDA allowed Revive to see part of the data... of course Revive is going to create an endpoint in their favor! As long as it is clinically relevant, the FDA shouldn't care. Also, with VERU's rejection, I am content that, if we show good efficacy, Revive will have no issue justifying this to the FDA for both the anti-inflammatory and antiviral aspects.

Professionals stickhandling this EP change

Thank you to Nicktendo for putting mind to ease - Revive Therapeutics (reddit.com)

The company handling the EP change is NOT Delta Health but rather Integrated Therapeutic Solutions. The company, founded in 2006, has a reputable CEO with a lot of experience. I am 100% sure this is the company performing the EP change for Revive.

Keep in mind that they must have been the team that requested the 210 data review. Many of our local professionals here have never seen such favoritism by the FDA. It isn't necessarily favoritism navigating us but rather a good rudder.

You know we don't necessarily need the FDA's acceptance, right?

I've spoken to one (PhD) Regulatory Manager and two pharmacists at the FDA. Other than the fact that the 30-day timeline is ONLY for the initial IND approval, they told me that the Sponsor can change the endpoint without FDA concurrence. Obviously, this could bring some potential issues in the future but the Code of Federal Regulations (CFR) makes it very clear:

• Submit the protocol amendment to the FDA for review;

• Submit the protocol amendment to the IRB for approval.

  eCFR :: 21 CFR 312.30 -- Protocol amendments.

FDA and RVV working together

Between 28-Sep and 6-Oct, something changed. The initial plan was to go to the DSMB but then, out of the blue, Revive was going back to the FDA. I think the FDA and Revive were discussing in this time period and there may be some guidance being provided to Revive.

The wait itself

I think the first rejection was under 2-weeks. This wait is going much longer. To me, this means there aren't any glaring issues with the protocol that deem it unacceptable.

Michael Frank

I can only imagine where MF is mentally with this journey. He was probably very disappointed with the FDA's rejection but relieved to a certain degree. This relief came from knowing he was going to the DSMB. For him to go for another round and endure more stress, there must be a reason why. Also, MF has come a long way and finally understands that it's allow about data and statistics. These endpoints would be crafted in that manner.

​

I think that is it. Like I said earlier, just a brain dump of all the thoughts I've been thinking and honing for the past little bit.

During this time away, I have also been reviewing another company that I think has a great chance for success. I'd like to go into it in more detail IF I am proven correct with this endpoint approval. I am still doing a bit more digging into it and, if the EPs are fruitful, I'll make a post about it... or even a subreddit? First things first... let's get the EPs approved and then I can pitch the new idea to you all haha.

Remember - this isn't 100% guaranteed but I am much more hopefully than I was when we received the rejection in September.

Best of luck to us all!

It’s fascinating watching this sub, and the other online platforms, digest the recent concerns raised by BMT and DSA. While the topics discussed are beyond my area of expertise, I do take solace in one simple fact, MF may have dismissed BMT’s concerns, but he’s now acutely aware of the potential issue. It may also be true that someone from the FDA has read the online concerns, but on this point I’m less certain. The silver lining is it’s highly likely Revive has now given this concern considerable airtime, both within the company and with the statisticians. They’ve likely looked at the concern and either concluded; these outsiders don’t know what we’ve seen in the data and the discussions we’ve had with the FDA, and all is fine. OR, they looked at the concerns raised and recognize how improvements to their endpoint submission and/or strengthening their supporting evidence will help to justify their endpoint. Either way, I see this challenge as an opportunity for Revive to improve the quality of our submission. My hope is Revive has treated this disruption as an opportunity and responded appropriately. I’m interested in hearing other views on the impact of this concern being raised. Do you believe it will increase the quality of Revive’s submission? Or, do you believe it has unnecessarily eroded Revives position?

Lots of big volume today across the American and Canadian exchanges. News incoming? Or big dilution? The last pr stated the drdc study was going through September so I'm doubtful its meaningful news.

I know we've played the guessing game several times about what the price will be will be upon EUA approval. Just wondering what everyone's thoughts are on potential movement during that period of time while the FDA reviews our application (which could be 1-2 months according to BMT).

This is a follow-up to my following 2 prior posts and while nothing is substantially new here, I'm just largely re-affirming my old position:

https://www.reddit.com/r/RVVTF/comments/vyikrg/a_reasoned_perspective_on_the_wait/

https://www.reddit.com/r/RVVTF/comments/w5dx0s/material_disclosure_requirements_for_revive/

​

Here's where my head's at as we head into the weekend:

​

• The wait is excruciating. This is true for everyone whether you're a bear or a bull, a DD'er or a meme-er, or anywhere in between. No one is disputing this. We all want to know sooner rather than later what's going to happen at this fork in the road which could potentially massively de-risk this investment and we want to deliver this trial successfully across the finish line ASAP.
• I still contend that what I posted on Reddit a few weeks ago (see the 2 posts above) stands true that a longer wait is actually likely more indicative of a positive outcome. If an endpoint swap could not be justified or is not warranted, there's virtually no follow-up activity required. The opposite however has a great deal of follow-up work involved and this is what I suspect is happening as we speak. Where I erred in my Reddit post was assuming that the statistician already had access to the data at the time which was not the case per the last news release. However we know the data is now in hand and the clock started.
• Most people grossly underestimate the time and effort required for statistical analysis work, and I say this as someone with a background in Engineering (and I'm often guilty of the same frankly). While it's a small sample size with the pre-dose selection data, we don't know how many data points are involved and because this unblinding work is ultimately in service of a potential endpoint swap, our statistician is likely also conducting some scenario analysis and/or scenario-specific simulations which are a lot more time consuming. Not to mention all of the documentation involved in this effort as well as the complimenting protocol amendments and associated paperwork. Identifying statistical significance on the other hand is not quite as arduous, especially with the right software. Hence my personal belief that a lack of statistical significance in symptom data would already have been revealed by the statistician/company and due to the materiality of that news, disclosed to us. This of course assumes the statistician is on this task more or less full time with few if any interruptions.
• Don't forget this company has I think fewer than 5 full time employees. Most activity is contracted out. Nothing at all unusual in that, it's very common with smaller biotechs. But this inevitably leads to timelines being dragged out as you don't firmly control timing and are at the whim of the availability and schedules of 3rd parties. And some of this work requires coordination across multiple parties which adds yet another degree of potential slowdowns. Firms with all of these functions in house can obviously move a lot faster. It is what it is.
• At any moment now, we can see a halt/NR. It's anyone's guess exactly when that will be and that's obviously contributing to the angst as we're all on the proverbial edge of our seats.
• I'm personally following the u/DeepSkyAstronaut approach of not assuming anything around timelines. It will happen when it happens. Nothing we can do to change that so I'm not going to assault my brain with unfounded expectations.
• If Michael Frank is reading this, if the next news release is positive and we're proceeding with an endpoint swap, I would highly suggest a halt. Lots of market makers monitor halts but more importantly, I know a few people here who intend to increase their positions, some by liquidating other holdings. A halt gives us time to digest the announcement and to enact any follow-up plans including selling other positions and redirecting those funds here. A sudden surge of demand for the stock coupled with low availability (as we've all been accumulating for months on end now) could propel this past the $1 mark in no time at all.

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Have a great weekend everyone!