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You have a point! Even if the data shows that we should stop the trial, we should continue the trial and wait for however long it takes to finish the trail, instead of approving the drug and treating everyone now. Those last few cases are invaluable... we need the data! What do you think about starting a petition?
The only explanation I can come up with is... flying under the radar... or we're too small and unknown to be getting attention at this point.
So... to do a little poking, I tried emailing them at the email address at the end of the video and got this...
This is a system-generated message to inform you that your email could not be delivered to one or more recipients. Details of the email and the error are as follows:
<odfisherslane1@uc.nig.gov>: Host or domain name not found. Name service error
for name=uc.nig.gov type=A: Host not found
Eh... who cares... this will change shortly anyway.
They're talking about covid drugs now. Not sure if they will mention rlftf, but I'm tuned in.
https://videocast.nih.gov/livew.asp?live=38836
Yes... Unethical... because those 40 patients located at just a few hospitals is just a small portion of the thousands of patients they represent at all the other hospitals. Think of it like this... if we continue to collect the 40 additional patients in trials, that will take another few months... how many people will die during that time?
Ok... I see that, but my point/questions are:
1) when is that meeting scheduled? I haven't found it yet. The meeting date would give us an exact day and could potentially remove some ambiguity.
and
2) is that meeting private and intended to only make an internal decision, and thus will still require additional time to prepare and make an official announcement? OR... will the announcement be made at that time (at the meeting or shortly thereafter)?
Because with a strong P-Value, it becomes unethical to continue trials.
The P-Value determines the possibility that the results we are seeing are wrong. The stronger the P-value, the less chance our results are a mistake. A P-Value of P<=0.0001 would be sooooo strong, that it would be unethical to continue trials. In other words, if you are THAT CERTAIN the drug works, then stop the trial and quick giving the dying patients a placebo, because they will continue to die at a high rate, so we need to stop and actually give them RLF100.
You asked: "Why NOT finish recruitment and collect firmer data?"
Because trial placebo will continue to let people die.
Well... the first 21 patients showed a P<=0.0001, which is WAAAY better than the FDA wants to see. Since then, Javitt has mentioned that they are seeing similar results with the "open label" patients (which are results the company has seen, but we have not yet seen, and we suspect that data has been shared with the fda), and in addition to that, we are expecting the unblinded peek at the 102 patients in 2 weeks. If we end up with a P-value anywhere close to P<=0.0001 with all that data, then it would be unethical to continue trials. Javitt seems to be expecting the trials will be stopped in 2 weeks:
"The Covid study is moving forward with incredible velocity. We expect to read out the Phase three trial by the end of the year. But, two weeks from now, there's going to be a meeting of the data safety monitoring board (DSMB). And they're going to review the first 102 patients in the trial. They have the potential to see both futility, which we hope they won't see, or perhaps they will see overwhelming evidence of efficacy. Either, which would lead to STOPPING THE TRIAL."
What I'm saying is that Javitt confirmed it will be the DSMB who is going to review the 102 patient data in their meeting 2 weeks from now (see quote below)... that's new info to me. Yes... it lines up with the 28 days you are referring to, so nothing changed there, but the new info is that the DSMB meeting is the time and place (eliminating some ambiguity)... and so from that perspective, please reevaluate my questions below. Also... Javitt is now seriously anticipating the trial will be stopped, whereas before, it was just a "possibility". There's a lot going on in this one quote:
"The Covid study is moving forward with incredible velocity. We expect to read out the Phase three trial by the end of the year. But, two weeks from now, there's going to be a meeting of the data safety monitoring board (DSMB). And they're going to review the first 102 patients in the trial. They have the potential to see both futility, which we hope they won't see, or perhaps they will see overwhelming evidence of efficacy. Either, which would lead to STOPPING THE TRIAL."
I don't know about you, but I get the sense Javitt is expecting them to stop the trial at the DSMB meeting, due to "overwhelming evidence of efficacy".
QUESTIONS:
Does anyone know exactly what day that DSMB meeting is?
Also... do we think that is the day they will actually stop the trail and make the announcement... OR... is that the day they make the decision and then would need some additional time to prepare the data for an official announcement?
(Trying to nail down a realistic date we should expect to find out the verdict.)
Good post... and who knows who this will save in the future... it could be friends and family of the very people on this board.
Hey Guy... thanks for sharing the updated spreadsheet with revenue forecast. I was able to download it and play around and appreciate the time you took to build and make that available to us.
So just a little Friday analysis. Please help me take a closer look at Javitt's statement from the Solebury Trout presentation...
"The Covid study is moving forward with incredible velocity. We expect to read out the Phase three trial by the end of the year. But, two weeks from now, there's going to be a meeting of the data safety monitoring board (DSMB). And they're going to review the first 102 patients in the trial. They have the potential to see both futility, which we hope they won't see, or perhaps they will see overwhelming evidence of efficacy. Either, which would lead to STOPPING THE TRIAL."
I don't know about you, but I get the sense Javitt is expecting them to stop the trial at the DSMB meeting, due to "overwhelming evidence of efficacy".
QUESTIONS:
Does anyone know exactly what day that meeting is?
Also... do we think that is the day they will actually stop the trail and make the announcement... OR... is that the day they make the decision and then would need some additional time to prepare the data for an official announcement?
(Trying to nail down a realistic date we should expect to find out the verdict.)
Dude isill... thank you for that insight. I'm grateful you continue to return to this board to help warn everyone here of the terrible mistake we are making. You have a good heart, and we can't say enough about how generous it is for you to take time out of your day to come deliver this insight. We thank you so very much and wish you a great weekend oh wise one.
That's a great question!
"The SCIENCE IS AMAZING... but complete lack of ANY media is JUST DUMB"
I will leave the assessment of when to launch the media up to the leadership who is closest to the political and big pharma landscape... you're opinion of whether its "dumb" is irrelevant. What you can't seem to understand is doctors and investors WILL become WELL AWARE of our drug once this hits mainstream media, and that's not going to happen until we have the FDA green light and enough supply on hand TO HANDLE THE EXTREME DEMAND THAT WILL COME WITH PUBLICISING OUR RESULTS.
We aren't "advertising" yet, because we aren't ready, and when we ARE ready... we won't need to advertise... the media will come to us.
Settle down... Patience!
I don't know if its related, but I saw on the other board that someone was suggesting to start a fund/charity of some kind where investors could all chip in to help get rlf100 to people who cannot afford it. Maybe someone decided to move forward on that... idk.
You may have had an impact on this story being published... we may never know, but just imagine if you did and you attract just 1 investor who’s life is changed or what if this article reaches just 1 patient who’s life is saved.
It doesn’t matter if YOU were the one... it matters YOU made the effort.
Hehe... u WANTED it to say that :D
Me too!
Correct... another great find by Tigger! :)
I think you might be "seeing" it wrong...
The title is...
Relief Therapeutics (OTC:RLFTF): NeuroRx to list on NYSE via Merger
Which to me looks like this is an update about RLFTF stock for RLFTF investors, and that update is... their partner (Neuro) is seeking to list on NYSE via a merger approach.
That's why there is a colon (:) after Relief Therapeutics.
And then... in the article, it states...
"NeuroRx a company who is partnered with promising COVID-19 therapeutic maker Relief Therapeutics (OTC: RLFTF) has decided to merge and list with a NYSE company (3-6 months)."
So... the way the sentence is structured, someone could misunderstand that the merge is between Relief and Neuro, but in fact, the rest of the sentence says "merge and list with a NYSE company".
So... look at the article as an update for RLFTF investors... that's what I think it was intended to do.
But yeah... although the title is technically done right, it inadvertently comes across a bit misleading.
Thanks... we're all learning and many have done the same for me along the way... its nice to have a group like this to share ideas and answer questions.
The USA is the Major market when dispensing starts, we have most of the sick. Agreed 10 employees with only 1 CRO guy starting in Sept as CMO and 1 at SA Board. Nrx also top heavy too, IMO. I'd love to see their financials to gain a deeper understanding of compensation expense, but they certainly have a STACKED team that is extremely valuable for navigating FDA, government, big pharma, etc. Seems like money well spent if you can pull off a blockbuster drug or two. Development/cost$/logistics(?) of RLF-100 IV will be handled by RLF That's all being done through the manufacturing and distribution partnerships (edited)... the partnership agreement states that Neuro & Relief split PROFITS not revenues. I dont see where/how RLF fits into the new scheme of NRX/NYSE Bio co. It seems to me that they don't HAVE to fit in that scheme, but they could if GEM and all decide its best. But I see your point.
All eggs in the 102 patient review and not even talk of completing the first part of the IV 2B Trial, and nothing on amount of patients needed to reach statistical significance with the Phase 3 part. Seeing the last FDA update on approvals seems to show Full Data is King/Queen/Game or dont apply, IMO. Huge amount of 'Hope' for FDA EUA, general approvals on the 102. Guess Dr JJ/NRX feels no need for further plans. Kept pushing the 21 data. One of the slides on today's presentation showed a P<=.0001, so how much more certainty do they need for EUA? By the time we get EUA, I think there will be more discussion about full FDA approval. Also, there is more data they have on the open label trial.
EOD volume at SIX/here ? anyone have an opinion besides me. Price after this news. Creep up some, creep down some until EAU or full FDA approval
Right... Relief has a CFO (but not Neuro) and Neuro has a CEO (but not Relief)... this is probably deliberate, and we could jump to the conclusion that a merger is imminent.
But it may not necessarily be designed for merger purposes... it could be that both companies are very small and thus sharing resources at the moment per GEM for cost control and resource-leveraging purposes.
That's why I said yesterday that we could all have fun speculating all the different merger, buyout, exchange listing scenarios... we just don't know enough yet, but there are many possible routes... only GEM and teams have enough data/inside info to determine the most profitable route. Heck... who knows... they may have already struck a deal with Lilly, Pfiser, or J&J to roll the 2 companies up into 2 separate buyouts. All scenarios discussed thus far are excellent, viable ideas... and they all likely result in a big payoff for us!
You're welcome. It won't be undervalued for very long. Investors will come in waves... one after another after another... first wave being the EUA announcement and the media coverage thereafter... then the market will need a while to absorb the enormity of this opportunity for Covid and the many applications beyond Covid... then the full FDA approval... then the inhaler treatment approval... THEN... the inhaler for PREVENTATIVE USE... then no one will be talking about covid vaccines ever again :)
Yes... with the exception of the revenue share explained in my last post.
Ahhh... yeah... Relief owns it, and Neuro is helping guide everything through the FDA and then once approved, they get some of the profit from sales. Here's the crux of their partnership agreement:
"They have agreed that NeuroRx will lead commercialization in the United States, Canada, and Israel, while Relief will lead commercialization in Europe and the rest of the world. Profits from sales will be allocated to Relief and NeuroRx on a 50/50 basis in the U.S., Canada and Israel, 85/15 (in favor of Relief) in Europe, and 80/20 (in favor of Relief) in all other territories."
Yes... except they would have to get rid of one of their CEOs. (sarcasm)
Also... remember... GEM is the backer for BOTH companies, and GEM has a large position in both companies with lots of influence on what, when and how everything happens with the intent to maximize their investments ;)
Well... the reason you own RLFTF is for RLF-100... correct? So Relief owns the drug, and NeuroRX is selling it in the US, Canada and Israel... Relief will get the lion's share for the rest of the world (if we're talking about revenues). Also, there are merger and acquisition possibilities on the table as well for Relief... and Relief has ALSO stated they are seeking Nasdaq/NYSE listing.
I think most existing investors who are familiar with both companies will invest in both companies.
Nice work Guy! Thank you!!! Do you think those numbers at least "partially" reflect a potential Barda deal, or could we be talk'n more?
It's a leap, but I'd be willing to jump with you :)
You're famous!!!!!!
Whatever the plan, I'm sure this cat will be involved...
"...the appointment of Jack Weinstein as Chief Financial Officer (CFO) and Treasurer, effective immediately. Jack will be responsible for all duties pertaining to these roles and particularly for investor engagement, including with institutional investors in the U.S. and abroad. He will be based in New York.
Jack brings over 40 years of wide-ranging executive management expertise, including as a CFO, investment banker and consultant in the biopharmaceutical industry. He has extensive experience in finance and healthcare investment banking, corporate and business development, as well as FDA regulatory and intellectual property strategies. He has successfully completed a variety of corporate finance transactions, including public and private financings, as well as mergers and acquisitions. Before joining Relief, he served as Managing Director and Head of Healthcare Investment Banking at Avalon Group, Ltd., an independent New York-based boutique investment bank. Prior to that, he was Chief Financial Officer, Treasurer and Vice President of Business Development at Catalyst Pharmaceuticals, Inc., a biopharmaceutical company developing prescription pharmaceutical products, and took the company public on Nasdaq. He also was President and Founder of The Sterlington Group, Inc., a consulting firm providing strategic, business development, regulatory and “CFO” consulting services, including M&A advisory and raising equity and debt for middle-market companies. "
"Still in the red"??? Are you in the red? Ohhh... maybe because you sat around complaining too much and then finally bought when it was at the peak... ok that explains why you're always complaining... because you don't know what you're doing. Makes sense now.
Oh yeah! I almost forgot about the OS!!! Thank you for the reminder again!!! Much appreciated.
Haha... the library is fake tho
He's stick'n to his "28 day" timeline, so that's good.
Absolutely
I agree... but additionally, they are also strategically connected through GEM, sooo... some of these co-mingle ideas aren't too far off base. But I agree... for the most part, they are 2 separate companies with roughly a 50/50 split for US business... is the best way to think about it until we hear more.
This is certainly possible.
No... Relief is not the merge partner Javitt was speaking about.
Relief owns the drug via patents... both the drug and the synthesis process.
Neuro could buy the drug... anything's possible, but that's not where they seem to currently be heading... but if they did, stock price would reflect.
Impact is described here...
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=158901655