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Pretty sure it’s because their endpoints are for day 29 and not 60 days-
https://clinicaltrials.gov/ct2/show/NCT04317040
The FDA just published updated guidance for Therapeutics. They specifically mention—
• In their endpoint definition, sponsors should address the occurrence of relapses to ensure adequate assessment of the durability of response
Link: https://www.fda.gov/media/137926/download
FDA has also revised a second guidance covering drugs and biological products more broadly for COVID-19, COVID-19: Developing Drugs and Biological Products for Treatment or Prevention.
Updated clinical trial
I sure hope so!
Is Aviptadil included in one of the ACTIV trials?
Thank you Mr. Know It All. It’s almost funny because I have figured out how you are going to react to absolutely everything.
Thank you JB! Well good lord the anticipation is killing me. Going to be hard to wait another few days if it doesn’t come out before market open tomorrow.
OK FITBIT WE ARE BORED WITH YOUR TIRADES.
We get it. You think it’s SH$T. So go already!
I would think this is a good sign for future good news.
They aren’t going to spin their wheels.
Ask him! Let’s get this moving. But please ask in lower case ;)
Gilles Della Court posted on LinkedIn with 3 screenshots from the NIH corona treatment guidelines, with no comments. Pages only mention remdesivir, etc the ones already approved. If you look at it, looks pretty sad and like we really need something NEW....Wondering if he’s T-ing it up for news?
Screenshots are from This doc-
https://www.covid19treatmentguidelines.nih.gov/whats-new/
Read out data- found this little tidbit. Says it’s when the data is made public-
The readout is essentially when the results of a clinical trial are made public. It can take a long time (in the case of my last company over a year) to get enough patients for a larger clinical trial to be able to show efficacy at a significant degree. So once you have enough patients that have gone through the treatment cycle (patients will all go through treatment cycles in their own time frames, you don't wait for everyone to go at once) you accumulate the data and comb through extensively and basically try and make the case for your drug if possible. When those final analyzed results are given to stockholders and people not directly involved in final analysis, that's the readout. A readout is a massive thing for small companies that depend on positive results to stay afloat and keep getting invested in.
Phew thank you J-B
Just saw on stock twits that brpa filed a doc with the sec and indicated that read out data is Jan 28. Tomorrow!
Yikes. Is this bad news? Apologies for not totally understanding this.
Which quote can you post it please
I love the way you think that a small company waiting for fda approval, just like anyone else, doesn’t ‘care’. They are just so mean!
2 questions- 1. My Stocktwits account has been suspended? Totally random. Anyone else had this problem?
And 2. When do we expect the SP to go up today or not until trial news?
Can you post a link please?
Thanks for posting. So with that article, seems like we should be hearing something around January 28th? Thoughts? It’s so hard to wait ;)
As I said before- does it matter? As long as they are IN!
Patience is a real virtues if you truly believe in what the company is doing. Regrets suck. Such as—I bought $NIO at $1.50 and sold it around $10. Now it’s $60. The pain. I was in a hurry and that is a great example of having a little patience ;)
Isn’t it true perhaps that being included in I-Spy is a big deal no
matter how it’s worded? If they are IN the I-Spy trials, that itself is a big deal. Thoughts?
Roofus all those initial caps must take a long time to write!
He might seem right at the moment. Even a broken watch is right 2x a day.
Thank you dms. I’m liking your thought process.
$RLFTF since the trial has been changed, they now refer to NeuroRx as the sponsor. The name Zyesami is changed toAviptadil. Where is Relief in all this? According to this filing they look like they ‘own’ RLF-100/Aviptadil. Anyone have insights? TIA
https://www.google.com/amp/s/sec.report/CIK/0001679768/amp
J-Belfort what is your guesstimate on timing?
Wow thank you dash ;)
BRPA is the one that is massively up. Can you tell me the difference? I just don’t know. Thanks!
Anyone know why brpa is doubling and is now halted?
I’d wait on the vaccine... Not great news:
NY POST: Critical Care Nurse
Caps make you seem like an unreasonable angry person. Just sayin
Thank you! He’s at st David’s north in Austin
Jonathan C. Javitt, MD, MPH
CEO and Chairman, NeuroRx, Inc.
I’m in Austin, TX and a dear friend is In the hospital with Covid, going on a week now. How can he get Aviptadil administered to him? I’m an investor and so excited to get this approved.
According to the 10k that was filed, they are going to proceed with a reverse split. See page 7. No timing on that one indicated.
Getting caught up on their filings!
@Julie 4 filings out this morning- 3 Qs and a K