Agreed. My pie in the sky hopeful guess... It'
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Posted On: 04/24/2020 12:10:03 PM
Agreed. My pie in the sky hopeful guess...
It's likely much easier for the FDA to expand access to an already-approved drug than it is to grant emergency approval and require a P4 trial. There should be very little in our BLA that the FDA has not seen. Preclinical should have been reviewed months ago, for example. Now, if the FDA could turn around this BLA in something like two months and grant approval...
…then you'd have an approved drug, with full CMC and safety review, that could be expanded into COVID use. Right about the same time that we'll have an appropriate amount of cleaned, randomized, double-blind, controlled data to make real assertions about efficacy in COVID-19. Those dots aren't too tough to connect.
Admittedly likely too optimistic, but hopefully the FDA is thinking instead of acting like a bureaucracy.
It's likely much easier for the FDA to expand access to an already-approved drug than it is to grant emergency approval and require a P4 trial. There should be very little in our BLA that the FDA has not seen. Preclinical should have been reviewed months ago, for example. Now, if the FDA could turn around this BLA in something like two months and grant approval...
…then you'd have an approved drug, with full CMC and safety review, that could be expanded into COVID use. Right about the same time that we'll have an appropriate amount of cleaned, randomized, double-blind, controlled data to make real assertions about efficacy in COVID-19. Those dots aren't too tough to connect.
Admittedly likely too optimistic, but hopefully the FDA is thinking instead of acting like a bureaucracy.
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