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Posted On: 07/19/2020 12:22:40 PM
Post# of 149200
Agreed. Provided the M/M results and subsequent S/C "interim" results are as stunning as we expect, I believe the FDA will issue an EUA for Leronlimab in early August.
As explained in this Remi EUA article from May:
https://www.fda.gov/news-events/press-announc...-treatment
Given what we know (8 years of safety with HIV) and what we expect (stunning COVID efficacy in phase 2 & 2b/3) I can't think of any better example of a treatment worthy of EUA given the circumstances.
And obviously I could be wrong but if the M/M & S/C results are great I don't expect a phase 3 being required for COVID.
As explained in this Remi EUA article from May:
https://www.fda.gov/news-events/press-announc...-treatment
Quote:
In determining whether to issue an EUA, the FDA evaluates the available evidence and carefully balances any known or potential risks of any unproven products with any known or potential benefits of making them available during the emergency.
Given what we know (8 years of safety with HIV) and what we expect (stunning COVID efficacy in phase 2 & 2b/3) I can't think of any better example of a treatment worthy of EUA given the circumstances.
And obviously I could be wrong but if the M/M & S/C results are great I don't expect a phase 3 being required for COVID.
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