“could mean that Amarex submitted data to the FD
Post# of 148170
(Total Views: 546)
Posted On: 10/20/2020 8:31:05 AM
“could mean that Amarex submitted data to the FDA on behalf of Cytodyn while still keeping it blinded to the company.”
Unlikely. The DSMC’s recommendation is clear, “The DSMC recommends the trial continue without modification to achieve the primary endpoint.” There is no reason to have the FDA review the data now and considering NP’s comment about not wanting “another strike against the company,” CYDY should wait until it’s appropriate to file for EUA. And, no, I don’t think it’s logical that Amarex would take the unblinded data to the FDA without allowing CYDY to see it and make their recommendation.
“If Cytodyn is looking for an early EUA we'll never know about it unless it gets granted.”
Unlikely. The PR is clear that the next opportunity for a halt and EUA application is the next analysis at 293.
Unlikely. The DSMC’s recommendation is clear, “The DSMC recommends the trial continue without modification to achieve the primary endpoint.” There is no reason to have the FDA review the data now and considering NP’s comment about not wanting “another strike against the company,” CYDY should wait until it’s appropriate to file for EUA. And, no, I don’t think it’s logical that Amarex would take the unblinded data to the FDA without allowing CYDY to see it and make their recommendation.
“If Cytodyn is looking for an early EUA we'll never know about it unless it gets granted.”
Unlikely. The PR is clear that the next opportunity for a halt and EUA application is the next analysis at 293.
(0)
(0)CytoDyn Inc (CYDY) Stock Research Links
Scroll down for more posts ▼