NEWS OUT : Revive Therapeutics Announces Submission of Amended Phase 3 COVID-19 Study Protocol to FDA

  1. The part of the submission that gives me confidence that the statistician team analyzed positive results is this section of the announcement…

  2. I hear what you're saying (and am hopeful that you're right), but I suspect they'd have the same verbiage regardless of of stat's findings.

  3. Interesting my wife noted that this press release seems to be written by someone different than the others and contains a link to the study. We are getting serious now fellas

  4. From the stories, I'm willing to say well over 80% efficacy for negative PCR test after 5 days. I wanna say 100% but that's unlikely.

  5. BMT, what are your thoughts on using PCR test as primary endpoint? At first glance I was excited because it seems more objective than symptoms, but it also seems higher risk since we’re not getting any data between 1-5 days and idk how many people test positive on day 5 even without intervention.

  6. So, regarding the endpoints, we chose those as optimal for success, based off the information we had in the study?

  7. Let’s see if everybody was right and that this stock will finally move for us… de risk as they say so let’s go!!!!

  8. Me and GF expecting first child, cant say how stressed i am about putting all that in safe and boring etf. But we are again getting closer now. LFG!!! I like the idea of driving in Porsche to private school and $hit.

  9. Jesus Christ, you’re expecting a first child and instead of making sure they have a foundation you want to gamble your savings on biotech penny stocks for drugs no one’s asking for to… be able to drive a Porsche to your kid’s private school you can’t currently afford? Please try to make rational financial decisions for your kid, not ones based off your own wild fantasies for them.

  10. "These proposed endpoints address the shift in COVID-19 clinical outcomes observed over the course of the pandemic, and, therefore, may have more meaningful study endpoints for the FDA to consider for regulatory approval."

  11. At the shareholder meeting we have to ask very specifically why all these steps are taking so long... Not in a negative way just so we can try to understand.

  12. This has been fast to me...and I have invested in 100s of bios over the last 30 years....folks here have no perspective

  13. As rewarding as this news release is we are still on the sidelines with respect to a large share price increment. Needle movers will be feedback from FDA & DSMB, we might drift lower in coming weeks.

  14. :D Finally an update. Hopefully within a month the FDA approves it. The fastest i can see them moving after is about another month to have the board review the remaining data and submit for EUA if the data is good. So probably some time in November apply for EUA and then just wait for the FDA hopefully they don't take too long.

  15. This PR is awesome and I keep reading it and being more hopeful and happy. But I also wonder why RVV changed form “time to sustained clinical resolution of symptoms” to “time to clinical improvement.”?!!

  16. Skipped the first part of that sentence "the company has now submitted revised protocol". The "discussion" and "agreement" is to be done by the FDA over whether or not the accept the revision.

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