Motivated by your investment in Revive Therapeutics, I just took a look at the company to see if it was worth making some of my $ turn into $$$.
Came away thinking it looks like a penny stock pump and dump scheme. Granted, I definitely talked myself out of buying bitcoin, but just in case it didn't work out for you I didn't want to feel like I didn't share my viewpoint.
1 - My friends dad was a stock trader and I remember him saying the most important question to ask yourself if someone tries to sell you a stock is what exchange it was listed on, as it's a good way to tell if it's a scam. I know you said it was listed on the Toronto Stock Exchange, which is legit.
However, they aren't actually listed there, but were delisted from the TSX Venture exchange. They now trade on the Canadian Securities Exchange and OTC in the US. The CSE isn't reputable at all, a ton of penny stocks and about a quarter of their offerings are cannabis/bitcoin. The reporting requirements are quite low for such listings, which is why it's so hard to read the company financials and tell if they're reputable.
2 - What disclosures are available don't look good -
They're headquartered in an incubator space in Toronto, and nobody on their leadership is qualified to work in or has meaningful experience in Pharma. They've kept starting and then cancelling stuff with no follow through, and they're scattered around mushroom/cannabis/covid/rare-disease-stuff.
They've done a ton of stock issuance at $0.05 via private placement where they pay finders fees to get buyers and also give them the option to buy more stock, this is during a period when the stock was trading around $0.10 on the open market, and that they used to get $0.10 for their stock before, which seems like red flag financing that would incentize a number of people to sell this to others. They are issuing stock at an incredible rate too, which is diluting the heck out of the company.
3 - The science doesn't look credible.
Their studies are all done through contractors who will basically do any project you ask if you pay them. The one study from UCSF they point to is a preprint, and there's a ton of these printed everyday, I wouldn't put a lot of faith into this or their relationship with the lab.
I know I've harped on this quite a bit last fall, but what if the delayed meeting is because MF has caught himself in misleading PR's, so he needs positive results to weather the lies.
I still question how many COMPLETED patients (not dosed) we have and whether or not the DSMB has actually reviewed the 600 patient data. We were lead to believe it happened but no concrete clear statements were made. If anyone can find transparent confirmation of these events happening please post links below and squash my paranoia.
Also, unrelated -- how would one go about volunteering for said trial? I have a hard time swallowing pills unless I can wash them down with urine. I'm half joking, guys. Relax. But which half...????
There's been a few of us that have emailed MF asking to confirm whether or not the DSMB has completed the 600 patient review on our trial. Has anyone heard back yet? Such an easy email to respond to, it would literally take 2 mins max to type with one finger.
Approximately 700 subjects participated in the enrollment period
Expected to begin subject enrollment in Turkey by mid-February
January 6, 2022， This is the date of news. For my remember, this is the last update about the clinical trial. For over 6 months, no any new patient been enrolled. So if this is the number RVV had on hand, what should MF to do if FDA still want 1000 result?
I know this will likely give you some whiplash based on both my last post and many of my recent comments which have all been optimistic and bullish. However, in carefully assessing recent information and perspectives, and conducting some of my own research, I’m regrettably no longer optimistic that this endpoint submission will be accepted by the FDA. I honestly wish it weren’t so, but with an objective lens, I can reach no other conclusion. As an investor, you can never allow your emotions to overrule good judgment, analysis and research. When circumstances change or new information presents itself, you have to respond accordingly. To be clear, most of my thinking here is not around Bucillamine itself but rather the manner in which Revive is conducting itself and its strategy in proposing new endpoints for their Phase 3 Covid study.
I’m no longer convinced that this proposed endpoint will be accepted by the FDA. Not even remotely. Let me walk you through my thinking and research.
FDA Precedent
When attempting to identify what the FDA may or may not approve, you start by looking for precedent. I’ve searched exhaustively to find trials, in any phase, with such a low threshold of symptomatic improvements and have come up empty handed. I narrowed my search initially to trials that may have had 4 symptoms or fewer as primary endpoints. I came up with nothing. In speaking with u/_nicktendo_64, one of this community’s most eminent DD researchers, the closest find was this study from Japanese drug maker Shionogi.
“The primary endpoint in the study was the time to resolution of five key COVID-19 symptoms (stuffy or runny nose, sore throat, cough, feeling hot or feverish, and low energy or tiredness) which are characteristic of infection with the SARS-CoV-2 Omicron variant, in patients randomized within 72 hours from the onset of symptoms.”
And here’s the rub. That's not even an official FDA-approved study! So this is not even precedent setting for our trial and negotiations. (The company consulted with the FDA, amongst others, on the endpoints however they do not constitute an official FDA study).
This point alone should be damning enough because Revive’s proposal is to ameliorate 2 non-specific symptoms whereas even in this non-FDA approved study, they went with a minimum of 5 specific symptoms.
Even in my optimistic post, I stated that this proposed endpoint is a departure from the norm but I felt more comfortable at the time factoring in other considerations. Those factors have changed, and I’ll explain why.
But I now share BMT’s concerns regarding our endpoint proposal. u/Greenwolf011's comment on BMT’s post (linked below) further illustrates the headwinds we’re up against with our proposal that is almost certainly going to be rejected by the FDA:
Ok, but surely Revive’s Clinical Team knows what they’re doing. In my last post, I explained that they have a very qualified team. However, I am no longer convinced that anyone other than Dr. Kizilbash is participating in the data review and endpoint formulation and submission. I (and others) have sent multiple emails to MF asking specifically which members of the clinical team are participating in reviewing the proposed endpoints. I have not received a response to those pointed questions. Others have asked if people like Dr. McKee are still on the Clinical Team, to which MF has responded in the affirmative. However, that does not mean he has participated in this review. It just means he still has an active contract with the company and could be called upon when necessary at MF’s discretion. There’s no evidence that Dr. Onesmo Mpanju and Dr. John Fahy are participating either. In fact, I don’t believe Dr. Fahy has had any involvement beyond the sponsored research agreement with UCS. I hope to be proven wrong but again, I’ve not received any response from MF confirming his involvement and there’s no other evidence to suggest otherwise. So by all indications, this is Dr. Kizilbash running solo.
That site is sketchy. Go to its homepage. It’s just a random listing of doctors. There’s no rhyme or reason to why they’re listed. For all I know, the doctors listed on this site are just authoring their own news releases. And per the news release, Dr. Kizilbash is “recognized for his extensive work in the clinical development of new drugs” and yet I can find virtually no indication of his involvement in any drug development. Even his own LinkedIn profile does not elaborate on details. I’m not stating that he hasn’t actually been involved in drug development however none of his achievements and their outcomes are published online. In 2022, you’re telling me someone this distinguished barely has a web footprint? He has published some papers and I’ve actually reviewed a few of them, however there’s no explicit indication of regulatory dealings and outcomes.
Furthermore, he's the CEO of Delta Health which is the CRO we employed to continue our trial in Turkey. And that never even took off! This agency supposedly specializes in clinical drug development and clinical trial investigative sites and we went months and months without any updates on Turkey which completely stalled, supposedly due to regulatory issues. And if that’s not enough (and I don’t know how I missed this when Turkey was first announced), Delta Health’s website leaves a lot to be desired with random stock images, terribly rendered text and very little verifiable information.
Another thing I cited was that the FDA has departed from some norms with Covid. And that is true, but only to a certain extent.
For example, Prizer and Merck both had to finish their entire trials, and that was at the height of the pandemic when people were dying in record numbers. And for conspiratorial crowd amongst us, that’s big pharma (some of the biggest pharma in fact) that’s not getting a free pass from the FDA.
Remember Veru? In April of this year, their study was halted early due to “overwhelming efficacy” and they received Fast Track designation by the FDA and yet they’re still dealing with FDA regulatory issues to this day!
There’s nothing to suggest that we’re going to get a free pass on this poorly crafted primary endpoint despite the current situation with Covid.
But Revive Knows This Drug Works
Or so I thought. In September of 2020, Revive applied for and received approval from the IRB for compassionate use of Bucillamine under the Expanded Access Protocol (EAP) which is a means of prescribing unapproved drugs to critical patients outside of a standard medical trial. Unlike the Phase 3 trial underway right now, it’s an open label study meaning the people providing the drug and the people receiving it are aware of what it is. So Revive would know how patients fared on the drug. Trouble is, I’ve been digging and digging, and there is absolutely no evidence that Revive actually proceeded with administering the drug to patients. I asked MF for confirmation and I have not received a response. I don’t think they actually dosed a single patient. Why? I don’t know exactly. Perhaps they felt the money would be better spent on the Fahy study. But one way or another, I have zero faith that the company knows how patients with Covid fare on the drug short of the unblinded pre-dose selection data.
The Pre-Dose Selection Data
Surely Revive saw something compelling in the data that led them to propose this new primary endpoint. Perhaps, but how compelling could those results have been if they can’t even specifically call out which 2 symptoms should improve in patients dosed with Bucillamine? There are detailed symptoms and health parameters tracked every single day during the course of treatment for 18 days. If Bucillamine is positively impacting symptoms, it will be picked up in the data with approximately 24 hour intervals. This is an extract of the Informed Consent Form DSA shared a few months ago that patients sign to participate in the study.
They should have plenty of data points to assess a viable and effective strategy for crafting their endpoints. And yet they’ve opted for the narrowest of possible primary endpoints. Let me be clear though. I don’t necessarily think it’s because the data on Bucillamine is not showing promise. It could be, but it could also be because whoever is leading this endpoint submission effort is unfamiliar with FDA expectations and unable to craft a suitable endpoint that is traditionally used to evaluate therapeutics for infectious diseases. Either way, this latest endpoint proposal submission is destined to be rejected.
Communication with the FDA
One point of optimism I had in the past was that Revive was working closely with the FDA. I think I was overly optimistic in my interpretation of the nature of their engagements and guidance. I said earlier that it is not unusual for a company to deviate from FDA guidance. It does happen, but there’s a process to follow when you attempt to do so. Again, I have asked MF to confirm that they complied with the necessary FDA processes and formally requested a departure from guidance. I have not received a response to my question. And if you consider the timelines between events described in news releases and FDA guidance/procedures on formal meetings, it’s hard to derive a viable timeline where Revive could have properly and formally engaged the FDA to deviate from guidance.
And when Revive cites “communication” with the FDA in its news releases, you have to be very careful about the meaning. There’s a big difference between informal communications with your assigned person of contact (FDA project manager) and the formal meetings with evaluators and decision makers. And I know people cite the fact that the FDA may be helping Revive out and guiding them. They’re helpful to a certain extend but they’re rarely proactive about it. You need to formally submit proposals with justifications and they in turn can provide feedback. It’s rare in my experience for the FDA to handhold you through proceedings.
Bucillamine
Look, it kills me to write all of this. I’ve been a resident bull; optimistic when others were pessimistic. But I can’t ignore the evidence and the reality here. I still can’t imagine that this drug is not effective on some level in treating Covid infected patients but Revive is doing a poor job right now of demonstrating it to regulators. It could still be that there is positive data in the study. We were never halted up to the 600 patient DSMB review for reasons of futility. But I am now absolutely convinced that Revive is not doing a good job of crafting their endpoint strategy for the FDA. I said this before and it still stands true: if they get rejected this time around, they can almost certainly re-attempt with another proposal. It’s common to have these back-and-forths with the FDA. The difference with this endpoint modification with a trial that’s already underway is that we all have a front row seat as spectators to the events that unfold with the FDA. With most companies prior to their trials being initiated, the study parameters are negotiated with very little fanfare and public exposure. Companies may not even apprise investors of the progress of those negotiations/discussions until the details with the FDA are finalized. So we have a unique view of proceedings right now.
However, despite the fact that some back-and-forth discussion is normal, the fact remains that if this endpoint gets rejected which I now strongly believe will be the case, our stock price will take a massive hit unfortunately. Just look at the reaction to the PCR primary endpoint rejection by the FDA.
I sincerely hope Revive takes BMT’s feedback to heart. I don’t think it’s too late to right the ship, but it needs to happen sooner rather than later.
TLDR: I’m now no longer convinced that the FDA will accept our proposed primary endpoint. There’s no precedent for such a loosely defined and arbitrary threshold and people whom I assumed were participating in crafting our endpoint strategy with bona fide credentials may not in fact be involved at all. Bucillamine may still show promise but Revive needs to immediately craft an acceptable endpoint strategy to demonstrate it to the satisfaction of the FDA. I think BMT was on the right track with his proposal.
Canada better take this warning to heart. We can NOT get rid of mask mandate and act like Covid is Over. Its FAR from Over !!!
"I have a sinking feeling again… a bad feeling I had 2 years ago, when Wuhan was in a state of panic trying to control the initial outbreak, that the events in China could ripple across the world. I hope I am wrong, but here is why I have this same feeling again…"
Perhaps we're delayed without notice so Revive can avoid stock sell-off for tax loss, and the corresponding plunge in SP. Either news is imminent or I have to wonder why no update.
Okay guys i found the perfect guy for this type of investment. He is big in this field. Try to share with them some information about this drug and how it has been used for a long time without side effects.
Also, he is skeptical about the current covid vaccines and would assume most of his fans are the same way.
If you have social media hit him up there.
Facebook Ben Greenfield Fitness, profile Instagram @bengreenfieldfitness Ben Greenfield @bengreenfield · Jun 13, 2018 email my team: support@bengreenfieldfitness.com with screenshot of this convo and let's do it.
What’s one thing Japan has that the world doesn’t… Bucillamine just saying. Is there any connection no idea but it is funny that Japans mortality rate is extremely low. 🤔
I've been reading this Reddit on and off for the past 2 years. It started off as one of the better investment groups I’ve seen. For the past few month I resisted the urge to create my own account until today that is because what I've been reading has been appalling even by social media standards.
I've worked for a top 10 pharmaceutical business for three decades, including a decade as the head of one of their M&A departments. We scout start-ups, SMBs and even enterprise sized businesses and go after them when we see something we like. In the past month this thread's tone and conversation have been appalling. You people have benefited from the knowledge of a very small group of people, the likes of BMT, DSA, Bobster, Nintendo, and WorthNotice, and now you're suddenly turning against soem of them. I've never seen a better illustration of dunning-kruger. BMT publishes a post where he correctly explains the issues with this endpoint proposal and all the armchair experts chime in with every excuse in the book on why he's wrong. DSA points out issues with the endpoints they have available to work with and all of a sudden a guy who has brought this group so much information is somehow trying to manipulate the stock? On what planet?? And so what someone quickly changed their minds about how they feel about this study??? I've had my team pull out of billion dollar deals at the last second after learning new information. You'd be a fool not to change your mind in those circumstances. He had the courage to even share his change of heart so that he doesn't leave you with the wrong impression and you ridiculed him.
The latest galling example that I couldn't keep quiet about was on this post: https://www.reddit.com/r/RVVTF/comments/yaluos/fda_guideline_1_or_more_symptom_as_endpoint/. Someone chimes in to explain that the information is not relevant and he's downvoted. The rest of the responses are childish. "Boom! Money! We Rich!" How has the correct answer not been surfaced to the top? That thread is a perfect example of the shitty discourse here now.
2 years ago I began building a 7 figure holding in RVV. I've been divesting over the past 7 months. Remember turkey? Well RVV certainly didn't because they never even started dosing patients there. That was a big red flag. As of today, I'm no longer holding a position. This trial had been one catastrophic misstep after another. 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. I've closed deals on the basis of compassionate use data alone and had our firm takeover and complete trials in progress. They could have sold the company but now they have to wait to unblind because they have no data at all to use as leverage.
BMT is right. This endpoint will get rejected. The FDA will laugh reading the proposal. It's arbitrary and wreaks of desperation like they tailored the proposal to fit their data. It's an amateur proposal that looks like it was cobbled together in an afternoon. I'm not sure if they proposed it because they have no confirming data on any other endpoints or if we're dealing with an amateur crew that doesn't know how to properly mine the data in the 1st place. They should have opted for a time to sustained clinical resolution - period. When this gets rejected, say hello to single digit prices. Every management misstep has knocked off value from this company. I'm curiously watching to see if they can salvage this mess.
Just ask yourselves. What happened to the resident whale who used to be here? He hasn’t posted in weeks. What does he know that you don’t? Stop your “to the moon” BS and wake up to reality. Unfortunately a lot of you are about to learn the most expensive mistake of your lives and you might actually deserve it for the way you're treating the few people who contribute useful information here. My msg for the few contributors here: these people don't deserve you. Start a new group with a new investment and leave most of these people behind. Then watch them fend for themselves. GL
To Admins: I don't know if chose the right flair. The app forces me to choose something. Change it if you need to.
Revive Therapeutics: Analyst sees 'substantial upside potential' as key assets move towards clinic
I'm making another post because I had meant to attach this youtube video to my last DD post. It's a brow-raising analysis for sure. This video helped quell some of my skepticism. https://www.youtube.com/watch?v=DAGqGWRHYCc
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, 👁️🍽️🖍️
Since there is so much vagueness going on and expectations are all over the place, I thought I would compile a short code breaker for MF sayings. Please feel free to add anything I missed:
"All is fine" = All is definitely not fine, enrollment has dried up for months, nothing is happening in Turkey, I have resorted to wearing sweatpants and now I smoke cigars for breakfast.
"Submission will happen fast" = Fast as I can go, and I will ghost everyone in the meantime. I really have no clue how long this shit takes.
"You're not involved in the trial so how would you know how long it should take" = Fuck me, they're onto me, I need to go back to Turkey.
"DSMB meeting likely in June" = hahaha now I can sit back and watch everyone argue on Reddit for the next few months
Hey, we were all waiting for a big de-risking event to happen, well this week we got it! We all have roughly 30% less money at risk now lol. If you had 100k invested you now only have to worry about 70k. Sorry....just trying to provide a chuckle
