(Total Views: 531)
Posted On: 10/26/2020 6:07:25 PM
Post# of 154115
Change to 42 Days. Thoughts?
I agree with the content of your entire comment.
Why else would they increase the days to read out from 28 to 42, unless they thought there would be more deaths? And I agree that this can only "probably" help our p value.
My concern is that even at 28 days, that is a long way off into the future while Big Pharma firms with connections and lobbyists and huge budgets and influence, are frantically working on therapeutics. The idea that we will need more than 1 therapeutic, I agree and understand, but that still does not give me a lot of comfort. I don't trust the FDA to approve an therapeutic that is inferior to Leronlimab.
And also, I do not have faith in our FDA due to plasma and remdesivir approvals.
It frustrates me that if we were granted an EUA approval or eIND approval, that this would hinder our ability to enroll folks in our on going s/c Phase III trial. We should be capable of creatively fixing that.
I agree with the content of your entire comment.
Why else would they increase the days to read out from 28 to 42, unless they thought there would be more deaths? And I agree that this can only "probably" help our p value.
My concern is that even at 28 days, that is a long way off into the future while Big Pharma firms with connections and lobbyists and huge budgets and influence, are frantically working on therapeutics. The idea that we will need more than 1 therapeutic, I agree and understand, but that still does not give me a lot of comfort. I don't trust the FDA to approve an therapeutic that is inferior to Leronlimab.
And also, I do not have faith in our FDA due to plasma and remdesivir approvals.
It frustrates me that if we were granted an EUA approval or eIND approval, that this would hinder our ability to enroll folks in our on going s/c Phase III trial. We should be capable of creatively fixing that.
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