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When a company meets with the DSMB on a blinded trial the only folks that see the actual data is the DSMB. Revive did not see any of the 500 all they get is an over arching recommendation on where to go next. Officially unblinding the data will put all the raw data in Revive’s hands for the first time and stop the trial completely. This will allow them to package up whatever positive data they have in order to grab that partner or sell it outright. If they find positive symptoms reduction along with no hospitalizations or death; basically data that shows Bucillamine has promise it will put all investors in a position to make their money back. Don’t forget trials aren’t cheap! Revive’s current market cap is less than what they spent on the trial itself, crazy! Good luck!
Better to hold for 10 years than sell at these prices. Heck we're almost halfway there already :)
about the only good thing I see here is that with the data being unblinded (and I agree that they had looked at the 210 and 500ish) maybe a 'partner' that they may be talking to can now discuss with the FDA an agreement on a fresh study / endpoints and hopefully that partner has the expertise to run a fairly quick trial under new endpoints, Basically they waited too long the trial fizzled with no push towards enrollment.
I agree with you - no sense pulling the trigger here - I'll just hold tight and see what the next 3 - 5 years bring.
I hear you Gator. I still would have liked the PR to end that the trial is ending due to statistical significance. (w/o the likely being met). I'll be around waiting to see if we can get anything like a Tamiflu drug or possibly a partnership for a long covid study, but I'm not holding my breath anymore. If this stuff works for symptoms, like we think it will, we will likely get our money back. No point in selling for peanuts now.
ps. I still don't understand what is being unblinded. Didn't they unblind the 210 and recently look at 510? What is left? Maybe they are now looking specifically at symptoms for the 720 and the FDA will let it slide for a cold remedy. Other uses are there as well.
pps. We now have a 6 and dealer is showing an ace. Ugh.
ppps. Why not wait some more? Nothing more to lose now.
Today's news is good. When the trial began, no one could have anticipated how Covid would change. The primary endpoints that were set in 2020 aren't applicable. But @Revive_RVV has data now. Showing impact on symptoms is likely given everything we know about NAC. $RVV $RVVTF
— Revive Therapeutics (unofficial) (@revivethera) May 12, 2023
Patronizing little peasant aren't you? You misinterpreted my original post of course. Jog on, sad act.
I think it is clear I am not a Michael Frank fan but you are being a dick today with your posts content. We are all hurting and furious so have a bit of class eh.
The fat lady has sung. RVVTF now joins the graveyard along with RLFTF and many other biotechs attempting to profit off of COVID. IMO RVV has always been about shrooms anyhow. By his own actions, the CEO has made that clear from day one. I'm sorry for everyone's losses. I took some losses too, but fortunately I exited about the time RLFTF sunk, so I only took a small hit. I predict that within 1-12 months we'll see an R/S (just like what happened to RLFTF). RVVTF is an unprofitable company, and they will need cash to keep afloat. Unfortunately, small foreign biotechs (in this case Swiss and Canadian) have never been on the FDA radar screen IMO. GLTA.
Looks like legal speak for those who invested in the offering
Unfortunately the outlook is poor here
Anyone see this new disclaimer added in this PR?
“There can be no assurance that the Company will proceed with the clinical development and regulatory approvals of Bucillamine for COVID-19 in the U.S. and internationally.”
They would already be up over 10%
Anyone with any sense and a little powder would be taking a step back, calm down, look at that gap and buy while others are bitching like a bunch of woke schoolgirls.
Data is what partners want to see. That’s where the value is.
— Revive Therapeutics (unofficial) (@revivethera) May 12, 2023
Spending your money on golf beer and hookers. Shameful
You may be right for most investors but some can take a loss and then come back in if it smells better later. One thing you should never do is sell in a panic and especially when stock market first opens. Let it settle then make your decision. It's not doom and gloom yet. No one said Bucillimine doesn't work in some capacity.
Where all the Michael Frank fans at today?!
The fly sucks. It should have said something. Where's the swatter?
No use in selling at .05 anyway. Better to hope for a miracle than take a 96% loss as opposed to a 99% at this point
For me it makes no sense to sell. I lost just about my whole investment here. So the company is either going to go BK or be bought out. This is brutal news. Waited almost three years for this POS to fly.
I await his response too but by no means do I blame him for me staying in this until the end. I am always an optimist and whether I sell and take my loss or wait for it to go up again, which it will is all on me.
Appreciate your sympathy govprs. I don't care what the others say, you're a top fellow/girl.
Ouch, well, you win some and lose some. In the words of Jim Morrison, "This is the end." The hope of a big pay day is gone. The best you can hope for is a buyout and that probably will take a while. Probably time to sell, lick your wounds and take a loss, move on....
The pump and dump has materialized but who pays? Sorry for most of you here
“The Company believes that once it has completed the evaluation of the Study’s data, it could support further discussions with the FDA on potential new clinical studies and allow the opportunity to work with potential domestic and international pharmaceutical partners to determine a suitable regulatory pathway for approval of Bucillamine based on the evaluated Study’s data.”
This study is done and a wash apparently. Only way forward is a partner and new clinical trials for a “suitable regulatory pathway” which we all know how long will take. The fat lady has sung. How low does it go today? .2? .1? 0?
The DSMB recommended that the Study be halted early due to statistical significance of the primary endpoint likely not going to be met should the Study continue towards completion. Based on the recommendation from the DSMB, the Company has halted the Study and will now proceed to unblind and seek an evaluation of the Study’s data, including the COVID-19 clinical symptoms data (i.e. cough, fever, heart rate, and oxygen saturation) to determine the potential next clinical and regulatory steps for Bucillamine.
News out. The fly speaks...
https://www.stocktitan.net/news/RVVTF/revive-therapeutics-provides-update-of-phase-3-clinical-study-for-3x0it6c60rx7.html
ps. Endpoints suck. We knew that... More unblinding? What did they look at? Confused at the moment.
If only we knew what that darned fly knows!
Without partnerships this is toast. Why it took MF years to conclude that explains why this sits at a nickel.
GLTA
If I am not mistaken MF in his last comments mentioned partnership more than once. GLTA!!
They raise 4mil at .15 valuation what a joke
Nobody was stopping anything when viewing 210 patients. With the addition of 500 dosed at higher levels of Buccy, and a surge in covid cases, one can hope that it's zero for buccy and nine for the placebo. That's all. You can't blame a guy for hoping and believing. With capital running out, Revive needs a partnership and the only way to that agreement is solid data.
ps. GLTA
You do realize if that were the case they would have halted the trial 2 years ago to look at the data. Best case is placebo had a few hospitalizations and bucc had none.
That is my understanding, although Revive doesn't own the rights to Buccy in a few places in Asia, but, I believe, the rest of the world is fair game.
ps. We wait.
On good data would they be able to continue the study with new EP’s for FDA purposes while simultaneously marketing and selling it outside the US for immediate use in those countries that allow it?
I tend to agree with everything you stated, but the hail mary pass is that Buccy had no hospitalizations and the placebo group had eleven.
don't get too anxious - if they decide to continue the study, they'll probably need to still get an infusion from a partnership; change end points and start over. If they decide to stop the study they'll need an infusion from a partnership and restart a study with different / changed endpoints. Even if they say it's the greatest thing since sliced bread the endpoints are antiquated so they'll need an infusion from a partnership and restart a new study with different endpoints. I don't think with the current endpoints that the FDA will be impressed. The study just took too darn long with those endpoints.
Was MF in a good mood this evening? Did he play golf, smoke a stogie, etc. ? Rubber, where is that fly on the wall?
I'm looking for volume of 500,000 tomorrow.
ps. We will know soon enough, likely within seven days.
Hopefully the the outcome will have been well worth the wait.
GLTA!
Looking forward to the return of friends!
Cw,
I liked this post in stock wits hope he is right , heck I don't know about this stuff...
https://stocktwits.com/BaronXXII/message/526985259
copy pasted here...DSMB review should kick off with an "open" session where RVVTF may be present (to answer questions, frame the report, etc.)
They can then move to a closed session to discuss data. A possible separate executive session (dsmb voting members only) to vote.
If anyone outside RVVTF attends the open session (silent partner?) word would likely spread swiftly. Watch for volume tomorrow.
(Yes. I know it's more realistic that that any silent partner would just wait until the dsmb answer before "doing" anything.)
ps. better if I mute the dummy here from stockwits who does not know me at all lol....
And Covid is far from Over hardly any testing now,test not working on new variants etc..
Of course it’s covid https://t.co/b5UE9sg9Ty
— Chris Turnbull (@EnemyInAState) May 8, 2023
Dear Experts:
— Marvin (@MarvinH2_G2) May 9, 2023
Blue is seasonal
Red is not seasonal https://t.co/O9E1zExEYH
Maybe he wasn't and isn't so interested in pursuing a sales product in support of the covid biosphere. .
Thank you Senor! Look forward to it!
D!¢$ are swinging in the. no pun intended. lol
Checking in and nice to see everyone still around,lets get some good data and a buyout offer,we didnt wait all this time
for nothing.
Allow me to be the first to kick off the festivities for tomorrow. MF will be schmoozing in the morning with the DSMB to get this product to market in the states. After analyzing the amazing data, there will be a slight leak as volume mounts in the afternoon. Within one week, MF drops a press release with the results of the trial. If Revive continues the trial with a partner, so be it. If they get bought out, good. If the trial was a flop, it is an expensive lesson and a few more years of hard work.
ps. Yes. I am the king of $2 lunches, Gator.
pps. I expect to hear from Rubber, Blue, All, Cool, Eco, Gator, Nosnibor and others as we start getting psyched up for the results of the 720 patients. One episode will certainly end within a week. Will another begin? It's anyone's guess. GLTA. (even Snoopy)
Been super busy, thanks for asking. Been doing the stealth possum thing, and the fox thing, hunting and been research a lot of over lapping health-bio-chemistry research and helping the world solve a food problem can cattle feed problem. And watching some new Netflix shows while we wait for $RVVTF major off to the Moon rally news. I do read & scan posts here....
"Averaging Down" is a common tool investors use that gets them into trouble after falling in love with their investments. WE have all been victims of that.
My question is --- if the trial is a failure, will the pps fall further. Or is failure already baked into the current price.
I've always felt that the CEO had fallen in love with his shrooms, and never really gave much priority to Bucillamine as a covid therapy. He had plenty of time to prepare for an FDA green light to proceed, and instead he dragged his feet early on. He did not have his ducks in a row for launching a covid trial. That was my red flag. And the FDA is no longer under pressure to approve EUA applications for covid. Slow you blow, snooze you loose.
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Scientific Rationale of Bucillamine
Preclinical and clinical studies have demonstrated that reactive oxygen species contribute to the destruction and programmed cell death of pulmonary epithelial cells.1 N-acetyl-cysteine (NAC) has been shown to significantly attenuate clinical symptoms in respiratory viral infections in animals and humans, primarily via donation of thiols to restore antioxidant and to reduce the activity of cellular glutathione 2,3,4,5. Bucillamine (N-(mercapto-2-methylpropionyl)-l-cysteine) has a well-known safety profile and is prescribed in the treatment of rheumatoid arthritis in Japan and South Korea for over 30 years. Bucillamine, a cysteine derivative with two thiol groups, has been shown to be 16 times more potent as a thiol donor in vivo than NAC 6. The drug is non-toxic with high cellular permeability. The basis of the clinical study will analyze if Bucillamine has the potential, via restoration of glutathione activity and other anti-inflammatory activity, to lessen the negative consequences of SARS-CoV2 infection in the lungs.
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