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Posted On: 11/02/2020 10:26:23 AM
Post# of 148903
Dr Nader P. "asked" FDA for "feedback", regarding our gaining EUA m/m approval, while suppying the FDA with our Top Line Report on our completed Phase II m/m clinical trials, in which we achieved "Clinical Significance" on Primary End Point (a very difficult End Point to achieve) and also, "Statistical Significance" on our Secondary Endpoint of NEWS2 (which could be seen as equal to or more important than our Primary End Point). So the FDA says to wait and let's look at Phase III s/c data. Did they mean at completion, or at 195 Interim analysis?
Regardless, because of the dramatic increase in USA and global new cases, IMO, a reasonable and honest and aware person, would expect/ask/apply for the FDA to presently issue Leronlimab either EUA or eIND approval, at least for m/m and s/c. What do they have to loose? What do they have to gain?
Regardless, because of the dramatic increase in USA and global new cases, IMO, a reasonable and honest and aware person, would expect/ask/apply for the FDA to presently issue Leronlimab either EUA or eIND approval, at least for m/m and s/c. What do they have to loose? What do they have to gain?
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