Both the DSMC, Dr. Dhody, Nader and everyone else
Post# of 154122
(Total Views: 737)
Posted On: 10/23/2020 4:37:47 AM
Re: ClosetInvestor #62814
Both the DSMC, Dr. Dhody, Nader and everyone else seems to be operating on the supposition that an EUA is the same as a BLA. FDA guidance for BLA is "an effective treatment" with a good safety profile. Guidance for an EUA is "may be effective" with a good safety profile. p = .05 is better than "may be effective" and whatever our lower p value is certainly surpasses that.
Time is of the essence not only for patients but for approval of leronlimab. DOD says the emergency is over or a subpar drug gets approval in severe/critical we might as well shut down the trial and wait for HIV approval. And this I will lay directly at NP's door.
Time is of the essence not only for patients but for approval of leronlimab. DOD says the emergency is over or a subpar drug gets approval in severe/critical we might as well shut down the trial and wait for HIV approval. And this I will lay directly at NP's door.
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