The key is in the statistical analyses. 21 patients or 2 thousand patients matters less than a P-value <.001. Meaning it is greater than 1000 percent chance that the results are meaningful
Aviptadil is only approved for erectile disfunction; thus the need for new efficacy for Covid. Gotta go through whole process again because it's for a different use.
ED testing was done in Europe. But yes FDA even acknowledges the Safety of RLF-100 in numerous trials going back to 2000. None of the scientists I suspect had any doubt the RLF-100 was safe... It's a matter of if it does have positive results.
We have seen some speculative positive results but the FDA is responsible for Public Safety of prescribed Drugs and devices. They will require more data as we sit here on DAY 8 Since 9/17 and the EUA application submission to the FDA....
Just remember Gilead's last application took 14 days to turn around...to a yes! I said Yesterday I wouldn't be surprised by a PR stating one way or another approval or no as early as today... sadly that has not come about But Soon it will happen and likely Next week....Buy on pull backs
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