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Do you think 100 patients at high risk is sufficient for the FDA? Seems too small a sample size. Plus we know how slow revive moves. Getting to 1,000 could take them a year to enroll. “Time kills all deals”
Not to mention the cash burn.
Thanks Rubber the main worry is funding;) 3.m maybe left for what? Maybe get to 800 with high risk... then can that data get partner ?
Ps. I believe what Bmt saying is true we need a partner to hopefully get to 1000.
I sold my trading position for a small gain
Offsetting the ~1300.00 bag I hold
All those big shots talking about buying the dip lol
Don’t be a sheep… oh for many too late
All options were laid out by RVVTF in this press release. As you stated the only viable option at this point would be a BP buyout.
They do not have the resources to continue the study or start fresh. They never were able to get Turkey going. They weren’t even able to get to their target enrollment with the US/Turkey.
Their current and revised endpoints have been rejected by the FDA.
They admitted their study does NOT contain/meet the suggested endpoints from the FDA.
There is nothing left but bankruptcy. Dropping Bucci for covid and pivoting fully to shrooms or psychedelics which will be years of waiting for recovery of the SP.
Or
BP buyout.
Take $.10-20 cents and call it a day. Let the investors recoup some losses.
The market has spoken
Fake news? As in factual press releases FROM RVVTF
No BP is interested
Your not seeing anything but hope and prayers
Your missing it again
The market reacted to the next steps. Only option 4 re: strategic partnership is viable in terms of stockholder value and clearly no one believes that talks are happening cause the pps continues its downward spiral
Speaking as an uneducated (in this game) ruminant, the prospect of that cheap buyout is what keeps me here. Taking a step back from the emotions of recent disappointment it appears likely that such a plan is in the works.
We shall see.
Baaaah.
For what it’s worth one should not forget that this is a ultra high risk penny stock. Like soooo many others on the otc, the vast, vast majority in this category fail or R/S which wipes out the SH. I personally have war wounds. IMO only $ one can afford to lose should be invested here. Ihub used to have a ‘OTC Graveyard’ board. It was huge. They finally removed it due to it negative connotations. JMHO.
This sounds like a claim that and recognition that $RVVTF #Bucillamine can be taken market.
Hmm
"By the way, i agree with Biomedical Trader who stated a few days ago that the only good thing that can happen at this point is for Revive to partner with a company who knows how to take a drug to market."
If the market does not trust MF and $RVVTF then market should sell and move and molest some other actual POS stock.
I am buying more shares.
There is company, OTC company that is doing their study in India for just 1 Million dollars.
A lot can be done wit 4.3 Million dollars
What I want to know is which BP firm is paying to try to extort a deal with the $RVVTF CEO for a cheap buy out using hedge fund backed MM naked shorts and buzzard bait fake news thoughts to keep trying to drive the share price down for an oversold buy out/deal
It is all too obvious to one who has the things I have seen
Exactly. Our only hope is letting BP step in. Their funding is mostly gone. They have no patients to continue a study with new EPs.
EcoMike touts the $3-$4 million they have from their latest offering as if you can fund a new trial or scramble to extend the current with everything that is needed to be done on that little sum of money.
Biomedical trader has been right every step of the way. I choose to trust him over Mikes claims of buying opportunities and market manipulation as the reason this thing may go to 2 cents in the next week.
The fat lady has sung
Yes and per your words in red this is done. You said it yourself. The only options here are to sell off to BP to try to salvage this or pivot to long covid which would likely need a new trial and years and millions of dollars in funding that they do not have. The fat lady has sung
Lol made a submission that was flawed, inadequate and thus doomed to fail? You mean like the pcr request which was explicitly outlined in fda documents as not an adequate endpoint?
It seems very obvious that many here screeching daily never actually read, and most importantly UNDERSTOOD what the PR actually stated...............pay special attention to the WORDS IN RED.
"After a further in-depth review and analysis of the FDA recommendations with members of the Company’s clinical trial team, including its statistician, regulatory affairs, medical affairs, and clinical research advisors, the Company has decided that in the best interest of the Study to preserve and not compromise the integrity of the Study and keep the blinded data intact to support a potential FDA approval in the future. As such, the Company will remain with the current Study protocol’s primary endpoint of proportion of patients meeting a composite endpoint of hospitalization or death from time of first dose through Day 28 following randomization. Although the Study was originally designed for a ‘hospitalization or death’ primary endpoint, and it completed enrollment of almost three-quarters of the Study’s recruitment goal and recorded specific clinical symptoms (i.e. cough, fever, heart rate, and oxygen saturation), the Study was not designed to take into account all of the symptom assessments and supporting data outlined in the FDA guidelines to warrant a primary symptom-based endpoint for COVID-19 studies."
According to the RVV team (NOT ME), the reason they decided against going with the FDA's ep parameters is solely because the original trial was NOT DESIGNED to collect the data the FDA was requesting.
Essentially what would have happened if the rvv team had accepted those ep parameters and the trial data unblinded and presented for review, the ep change submission would have FAILED and as such been rejected by the FDA since it could never satisfy the standards set, ie you cant pass an English test by answering in Greek!!!!
I can only imagine the Nuclear Meltdown that would have occurred if they had decided to ignore the data deficiencies and knowingly made a submission that was flawed, inadequate and thus doomed to fail.
I am simply restating the official position of the company from the PR, not my own, but if you or any of the other banshees have evidence that their claim is untrue do feel free to present same instead of posting incoherent nonsense.
I have already indicated that the handling of this whole ep process has been, IMO, inept so I am by no means an apologist for those responsible for this farcical waste of 6-8 valuable months.
Now, TRY AGAIN!!!
I said the same thing
Management is so incompetent
Meanwhile if rvv just moved forward with the new end points. The data could be unblinded for all to see
Instead MF keeps you and the sheep in the dark hiding in plain sight
Horrible outcome here for all you 24-36 bag holders
Keep us posted and I think if investors was in the offering at .15 they are down 70%
Just saying
By the way, i agree with Biomedical Trader who stated a few days ago that the only good thing that can happen at this point is for Revive to partner with a company who knows how to take a drug to market.
Unfortunately, i agree with you. I'm not expecting a response from Michael Frank but this is what i sent to him today.
===================================================================
Mr. Michael Frank,
Per the latest Press Release…
“After a further in-depth review and analysis of the FDA recommendations with members of the Company’s clinical trial team, including its statistician, regulatory affairs, medical affairs, and clinical research advisors, the Company has decided that in the best interest of the Study to preserve and not compromise the integrity of the Study and keep the blinded data intact to support a potential FDA approval in the future. As such, the Company will remain with the current Study protocol’s primary endpoint of proportion of patients meeting a composite endpoint of hospitalization or death from time of first dose through Day 28 following randomization.”
It would appear that the clinical trial with it’s current primary endpoint is essentially ‘dead in the water’ because the current primary endpoint is essentially outdated and it’s apparent that Revive can’t pivot to another meaningful primary endpoint that would meet the FDA’s guidelines. For someone who explicitly became a shareholder in 2020 based solely on Revive initiating this Phase III trial, it’s an understatement for me to say that i’m extremely disappointed with Revive’s management, more so when i’m looking at my unrealized +90% loss.
The best hope that shareholders have at this point is for Revive to do a deal, collaboration, or a partnership with a bigger more experienced pharmaceutical company who could then try to help salvage this trial and navigate Bucillamine through the FDA approval process.
XXXXX XXXXXXXXX
Revive Therapeutics Shareholder
(By the way, do you believe the individuals who participated in Revive’s Offering months ago are just as extremely disappointed when looking at their +50% loss?)
===================================================================
Totally agree with Ecomike! It's a very volatile period, hang on to your shares.
Eco
Moderna got beat up today in Congress for charging too much for their experimental.shot! Lol
PayPal, Moderna, TeleDoc, and 1000s of other stocks got hammered down just as much as $RVVTF the last 15 months.
Real DD Matters
"Yes its all MM and hedge fund backed shorts running down the SP of everything on the stock market" Yep....
I’m also heave in this maybe more than you. No choice except to hold.
Question for me is getting to 800.
Yeah they burned through their cash going other directions, also got blindsided by Omicron I think. I want to see high-risk study participants and that review at 800.
My worry is how they get the funding as most...or partner with JnJ etc :)
can they do that with 210 data show what Bmt u etc thinks.. Good Data.or what left from the 4.3 m or whatever to only get high rishk, lol. I mean chit they got 23m funding for trial which is about 70% done. so maybe they got 3m left to finish,,,not enough if you see 20m only got 70% of the trial done.
Ps. Holding because of the science and a few smart DD people :)
pps. lol can someone delete one of same post well damn this northern lights vape has me to realaxed
Exactly the issue I’m raising they don’t seem to have a clear strategy
Trip, us other Longs are all pissed too but please don't be THAT guy who sold everything on Monday and now lingers on here bashing it all. Based on your historic posts, you are classier than that I think.
Didn’t RVVTF initiate the request for an endpoint swap around a year ago and now they’re deciding to not do it? Hopefully they have a good path forward
Yes its all MM and shorts running down the SP of a pennystock with no revenue and a flailing phase III covid trial that they’ve tripled over themselves every step of the way. Can’t be that
Nonsense, big pharma has lost trillions of dollars in failed drug trials.
$RVVTF is still in the fight and 7 years closer to an approval on a record breaking phase III trial that the market has ever seen on a small start start up sized firm in this sector.
Hogwash, it is naked shorts and MM games that are the share price problem.
$RVVTF Bear traps are set now.
That’s just examples that rvv leadership is incompetent when it comes to bringing a new drug to market
Complete gibberish.
$RVVTF is still in the game.
No one is questioning the back and forth which is a positive
It’s all up to MF to make good decisions on how to spend the millions he raised 3x the pps today
He’s not very smart according to the pps and the staggering losses by many bag holders here
When your good let em know it, right?
Really? So fda said we want these endpoints and mf said nope we are good with the old ones? That doesn’t sound much like a back and forth to agree on endpoints. That is the fda saying we will accept these endpoints and mf, in all his brilliance, saying no I feel like screwing everyone and wasting the past year so I will stick with the old ones. I’m sure you will have an excuse for that as well. Just make sure you buy all the shares in the next dilution to fund the rest of the trial that has no patients. It takes some sort of idiot not to unblind a trial that you know you can’t finish. At this point he is just dragging this thing out. Unblind and sell based on the pcr data and maybe they can salvage a couple hundred mill.
Yes and the PR is a written response to the public regarding said written responses from the GDA where RVVTF said no thanks we will ignore and continue with previous end points which were already rejected by the FDA.
Hospitalizations and deaths are no longer a thing to 99%+ of the public with these weaker strains. Hence why FDA wants time to resolved symptoms.
Does this drug help people who get sick with covid get better faster yes or no? That’s it. Thats what the FDA wants to know. Not whether they will die.
The FDA is looking for essentially a stronger Dayquil for covid. Plain and simple.
Revive is ignoring that request apparently. Or the data doesn’t support it. That simple
As recently reported by the Company, the FDA has granted the Company’s Type C meeting request to obtain agreement on the revised protocol endpoints for the Company’s Phase 3 clinical trial (the “Study”) (NCT04504734) to evaluate the safety and efficacy of bucillamine, an oral drug with anti-inflammatory and antiviral properties, in patients with mild to moderate COVID-19. The goal date for the FDA to provide its written responses is March 7, 2023.
TYPE C Meeting..............When requesting a Type C meeting, Sponsors can request a written response to their questions rather than an in-person meeting, videoconference, or teleconference. A sponsor may request a face-to-face meeting, but the FDA may decide that only a written response is necessary.
Yes, written correspondence would equate to a "back and forth" between parties.
Some should learn to Read and Comprehend before posting laughably mindless comments. lololsss
LOL 20 cents?! This hasn’t seen 20 cents in six months. Now its going to .20 on this news?! Pump pump pump
The last boy scout is buying them all
It ain't over till the fat lady sings. The US Banks crashed and burned and this week rose from the dead like the Phoenix rising.
RVVTF is up 66% in 2 two days on heavy volume since the opening crash monday, market sell (likely MM shorts tripping fools stop loss orders) And the shares I bought the knife on a day ago are up 20% today.
This beast could be back at 20 cents in week.
Did you sell all your shares or have you held on to all / some, Trip?
I wouldnt mind grabbing some more,just dont have any cash left right now.
Lotto ticket buys
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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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