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Yep. Any day now. That day could be today, or it could be in June. Depends if the FDA things 165 is a large enough sample size or if they would like us to go to 300 patients next.
That’s terrible news. Now we have to wait another 10months for EUA so they can make a new vaccine...
I’m just going to assume that it was a build up and sell the news event. The flippers knew the 165 enrollment news was coming. Kinda happens every time.
The article was news to me. But it also could be a case of the Mandela effect? I don’t know. But seeing that there was heavy speculation of EUA and unblinding of the data this month, I have a feeling many have missed the key date of January. Everyone wants transparency, I think for the most part the information is out there. But, the information is rarely centralized.
Bouncing between all the investor groups, just trying to dispel the myth that somehow we are going to get a DMC read out before Christmas. I get to see the same people day in and day out cheerleading green days then when we slip red they blame the Swiss market.
I’m not sure why you are getting so emotional about me posting that article? It was in response to Vanilla. Not you?
Relief pushes back data release date for COVID-19 study to January.
It’s all just a waiting game right now. I’m sure mid January is when we will finally see EUA.
https://www.reuters.com/article/health-coronavirus-relief-hldg-idUSL8N2HR1GQ
HEALTHCARE
NOVEMBER 5, 20202:54 AMUPDATED A MONTH AGO
UPDATE 1-Relief pushes back data release date for COVID-19 study to January
By Reuters Staff
(Adds details about top-line data release date)
ZURICH, Nov 5 (Reuters) - Relief Therapeutics and its private U.S. partner NeuroRx Inc. on Thursday pushed expectations for initial data from a clinical trial of a 50-year-old drug against COVID-19 to January, from this quarter as previously announced.
The announcement comes after a nearly 50% decline this week in the share price of the small Swiss company, according to Refinitiv data. The shares, trading at less than 1 Swiss franc, are still up significantly for the year.
Relief will continue the study of its drug RLF-100, also called aviptadil, against COVID-19 to its full enrolment of 165 patients after identifying no safety concerns, Relief and NeuroRx said in a statement, after a vote by its data monitoring committee on Wednesday to push ahead.
On Oct. 13, Relief and NeuroRx said results from the randomized, placebo-controlled study were expected “this quarter”.
On Thursday, they said in a statement that “at current rates of enrolment (which may change as infection rates change) the study is expected to complete enrolment by mid-December and yield top-line data in January 2021.”
“A couple of weeks after the end of the fourth quarter is what we’re expecting right now,” Jonathan Javitt, founder and chief executive of NeuroRx, said, telling Reuters that the new deadline reflects challenges in running a trial in the midst of a pandemic, including keeping staff safe.
Aviptadil, discovered a half century ago and studied over the years for a variety of uses including erectile dysfunction and pulmonary fibrosis, was part of Relief’s portfolio when the COVID-19 pandemic began, prompting the company to seek to repurpose it. (Reporting by John Miller; Editing by Michael Shields)
I’m going to assume since data won’t be read out until January we won’t have any significant news this month in terms of EUA. I’m going to suspect though in the first week of January people are going to start taking profits. One last nice dip before the rip?
Just a FYI I haven’t renewed my subscription on here since I’m not as active anymore. I haven’t been ignoring PMs just have no way of responding.
Check your email. Subject “Petition (insightfulpenguin)”
I was. But I scrapped the project shortly after creating it. While there was plenty of interest in it, there was also plenty of backlash that an investor had created this petition and most of the signatures were those of investors as well. I was hoping that someone else who has no financial ties to the stock would have created a new petition so there wouldn’t be a conflict of interest. I honestly though I closed out that petition.
One thing I would like to note from the change on the clinical trial page, the name Aviptadil has been replaced with RLF-100. Not sure if that’s a hint towards a rebrand soon.
It’s fine. Everything’s fine. Investors should not worry or care what happens to the S/P. They just need to have faith! Faith that the 1b new shares will never get dumped into the market! Faith that this pay raise that will dump 150m more shares into the market won’t tank the S/P. Faith that IF a r/s happens GEM doesn’t decide to sell shares or the company decides it needs more money and authorizes more shares to sell into the market! Faith that this stock only has upside even though the company is valued at 1b dollars with 0 revenue! And furthermore Faith that this is profitable enough with the Neurorx deal that the S/P can be warranted. After all NeuroRX is getting a 50% cut of revenue in the USA and 20% of European revenue.
The concerning part is the shares will be issued at .01chf and not at market value. How quickly do you think an institution could crash the s/p if they bought 100m shares for .01 and started cashing out immediately like most OTC stocks. Generally we are fortunate GEM has been kind enough to hold their position. But who knows with the next investor. Especially when you buy at .01 and could sell for .4 a day later.
Gotta pay their Christmas bonuses some how. Relief worked hard all year watching Javitt do all the heavy lifting. They need a raise for all that supervising.
Yep we seen that. So enrollment could end by this week. 28 day review starts shortly there after. DMC gets their chance to kick numbers around for a week. So January is looking good for us
Nope, but it was a simple wager I lost $ on. I was betting results would be 80%, my buddy was betting 70%. Guess I’m out a case of beer and 20$
Going red Swiss. The news just confirmed what the longs already knew. Actually made some of us a lier because I was telling everyone it was going to be 80% effective. One day of good confirmatory news does not make us any more profitable than we are now. As the revenues still remain 0 after the news. Also 1 day of good news does not answer the gnawing questions we have about the 30k doses in March statement. Or the fact that they are going to vote on dilutive financing in December that could be released to the market at any given date.
It’s not halted. CNBC is just bad.
That is something I can fully agree on. The lines between what Javitt knows and what the Relief team are telling him and us seem to have a huge disconnect. If Javitt held the patent to this drug and it was his company. I probably wouldn’t even check the stock movement and the PRs on a daily basis. But the Relief side of things and their staffing? I’m glad for them they are voting on giving themselves a celebratory pat on the back and pay raise. Look how much they have accomplished with their European trials. Look how much leg work and foot work they have done with PR and regulatory approvals. Oh wait... so far the only success they have to tout is they hired javitt to do something in 7 months that they couldn’t do in 15 years. So of course they don’t care about shareholder value. They don’t care if they balloon up the O/S to the 6b A/S they have.
Great relief is fully funded. Good for them. I’m curious to see what Javitts contract with them says? Does he only get paid on approval and revenue? Why is he continually having to present at these big investor meetings trying to scrape more funding? Is relief holding most of that $ in favor of the Euro trials that may or may not happen?
If Javitt told me the grass is blue, well I would grab a banjo. If relief was to tell me the grass is green, you can bet yourself im going outside to double check, might even have a few friends verify before I sign off on it.
The point is, there is so many misinformed investors spewing in about an inhaler. A grossly over abundance of people here and on other pages are expecting a physical inhaler of this. 95% of the talk is about inhalers. I’m trying to clear up that misinformation.
A video clip of an inhaler does not mean it was a video clip of inhaled aviptadil. How many news articles use stock photos or stock video clips they have for a visual representation? Show me a single piece of literature from relief mentioning an inhaler.
I would like you to point to a single statement from the company that mentions inhalers. I will wait.
Inhaled is different than inhalers. There has never been mention of an inhaler. The inhaled trial is for nebulized aviptadil.
I mean if you want to clutch at straws and pretend that the 30k doses promised by March is the inhaled version, by all means. Hang onto that dream. But that’s a strong assumption that the inhaled trial which has been pushed back by 3 months already, will be live, completed and approved by the FDA in less than 4 months. But hey, if moving goalposts are your fancy, then by all means, make assumptions. Just like assuming they were fully funded after 2 rounds of dilution that ran our o/s from 2.1b to 3.1b in 6 months and now they want to start diluting even more to raise more capital? How many investors have the presented to? 3-4 major investor conventions? Princeton angels investing. All this money rolling in and they want more?
Most investors lose their sh** when a company dilutes by 100m shares.
Seeing that the most recent EUAs granted were applied for after us. I would manage expectations accordingly.
As someone more qualified in chemistry than I am would say when debating disinfecting bleach vs household bleach vs liquid chlorine “Sodium Hypochlorite is Sodium Hypochlorite is Sodium Hypochlorite”
Aviptadil is Aviptadil is Aviptadil. Whether you take a nasal spray, insufflate using a nebulizer or take it intravenously. There is no difference between inhaled or injected versions other than preparation prior to administration.
And they also said they had 1 mil doses in the freezer last March. Now today’s news says only 30k doses anticipated for this upcoming March?
I have a hard time believing Javitt would misdirect us. I’m starting to believe though that he is not getting the whole story either. Is Relief just BSing all of us and feeding Javitt half truths? He seemed to have slight levels of frustrations during his video conference with the world health leaders group. Can we really trust at this point GEM and RAM not ripping the rug out from under Javitt and the rest of the investors come approval? Why not? Javitt is going to take a 50% cut of US sales and 20% of global sales. This is frustrating.
I think we are speculators at this point. I see no evidence of our shares purchased going directly to relief or research. All of their funding has came from GEM. The shares we buy and hold now have already been sold and circulated on the market. Now if you wait another month, there will be a few hundred million more being minted and sold, if you would like to “invest” I’m sure they would gladly sell you those to pay their salaries.
How is that glass half full? We got a couple hour lag behind the Swiss markets, so any run up will be dead from dilution by the time us markets open 6 hours later. That many shares could last a few good days to sell off. Momentum usually dies after 2 days of light dilution. 1 day of heavy dilution. By the time December rolls around we would have lost the “first to the market hype” in reality we will have post vaccine and a slew of other EUAs already killing any excitement by December
Why wouldn’t they? Vote in December to give everyone a raise starting the new year. Where’s the money going to come from?
The dilution is voted for on in December. So sounds about right.
30k doses by March = enough for 10k patients per month. Or 3-5 days worth of demand.
Do you think inhaler is slated for approval by March?
30,000 doses by March? Wow! Look at that. So what happened to the 1m doses in the freezer? Or the ramp up that was supposed to treat 100k patients by last month? These goalposts keep moving.
I think we all had concerns, but confirmation bias really blinds the herd. At this point I’m not sure what’s hitting exponential growth faster, this pandemic or the O/S. We’re not talking millions of shares. But rather billions of shares dilution. I originally invested with what. 2.1b O/S in august. Already a steep hill to climb. But here were are over 3b and climbing still
Correct me if I am wrong. But did they not already state they were funded through 2021/2022? Now they want to dilute this stock even further to raise more funding? At what point does the shareholders take up legal action for being mislead by company statements? We factored in GEMS warrants into the dilution. That’s all baked in. But what was also baked into the share price was the fact that they told us the company was fully funded for another year. We have had how many PRs fluffing this over the last few months. Great and exciting world shattering things. So when are we going to get a peer review on all of these preprints? Next week is the trial size going to be increased to 201 patients? After they hit 185 are they going to increase the trial to 250?
This is some grade A BS happening. The goalposts keep moving. The shares keep getting diluted. Management wants a raise on the backs of the shareholders while we are stuck holding the bags.
I’m starting to wonder if the FDA is holding this up until after a vaccine EUA or approval. If this drug is 80% effective at reducing mortality, that brings our daily fatality rate as a country down around 200-300 deaths per day, decreasing the CFR to near flu levels. But as we are seeing, given early in treatment, this is more effective than being reported as study results are based around people who are already critical. If this was given at first need for o2 support instead of after the patient has “crashed” then we are looking at levels well below flu deaths.
What would happen if this drug was approved prior to a vaccine? Simply put, far fewer people would take the vaccine. There would be no possibility of eradication through vaccination. Compliance for social distancing and masks would plummet. Cases would sky rocket. The government is way to invested in vaccines rather than the herd immunity approach that this drug would allow for.
If you have me the option of a rushed vaccine vs taking my chances and getting an aviptadil infusion if I get sick, well personally. I would take my chances with the aviptadil infusion. And tell Pfizer or moderna to take their vaccine and toss it in the garbage.
I have a few bucks stashed away if this dips when moderna news comes out. But I think everyone is anticipating it so it won’t be that big of a pullback like previous dips.