Wednesday, September 28, 2022 10:44:23 AM
"The only part I understood is when you said you don't have time to respond to the third prompt. "
Today's miss understood news, and 50% drop, is because the market does not think first in this kind of market, it knew jerk reacts, trips stop loss orders and triggers volume.
What they missed, is that the FDA did not say no, the study is over!!!! If there had been bad news in the first 210 person data set, the FDA would have said:
'This study is over, treated patients died, placebos did not', or some such reason to kill the phase III trial. The FDA instead gave them options to move forward...
The FDA instead, said we need more data. Either the rest of the 500 or the 500 plus more from a completed trial. Since we do not know what the data is in the last 500, we must wait now. We already expected that folks. So this dump, was just dumb and dumber giving us one last chance to bottom feed, and add...
It only seems reasonable that since the FDA has opened the door to a meeting, we could tell them the long haul covid is now, also why the FDA needs to move the end points and let us get approval"
IMO, the long haul covid application could be worth 10,000% more that 1 week dosing for active infections...
I want to know how many Placebo people got long haul covid19, versus the ones that did not...
To me, the fact the FDA did not say no, is huge.....
They said they want to know why and want more data...
they also said:
"the FDA provided communication that the amended protocol is still under review"
"the FDA has advised the Company to submit a meeting request to discuss the appropriate endpoints and justification of the relevance of the revised primary endpoint. As a result, to potentially obtain FDA agreement and strengthen the relevance of the revised endpoint, which relied upon the Study's Pre-Dose selection data, the Data Safety Monitoring Board ("DSMB") will review the completed Post-Dose selection data of approximately 500 subjects."
More news cometh folks!!!!
7th-inning stretch time.
Was this not not what we expected a day ago???
It is the kind of news I expected. It means the 210 patient data set is OK. As in there was no bad news end to the study news in the first 210 patient data.
It means the FDA wants a meeting!!! To discuss and help $RVVTF plan and know what they should do next and how to do it
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