Love your posts Tech. I am in full agreement. Th
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Posted On: 03/06/2021 12:42:32 PM
Love your posts Tech. I am in full agreement. The worst case scenario as I see it, is that we dont get an EUA until we increase the n (even if a completely new trial)
Obviously a set back in the timeframe sucks, but we know the drug works.
Now the question becomes will the US or any other country take a leap of faith and give an EUA. TO me this is the only real question remaining.
If we get an EUA anywhere, that is tied to a phase 4 trial, we will be able to collect massive amounts of data in short order. My hope is that the agencies in these countries agree. Perhaps the Phillipines or Brazil agrees, and we are able to treat a thousand people over a short period of time and give that data to the FDA.
In a normal world, they would require a new trial. But we are in a pandemic, and Janet Woodcock as made it crystal clear that statistical significance is not a requirement for an EUA.
Time will tell.
Obviously a set back in the timeframe sucks, but we know the drug works.
Now the question becomes will the US or any other country take a leap of faith and give an EUA. TO me this is the only real question remaining.
If we get an EUA anywhere, that is tied to a phase 4 trial, we will be able to collect massive amounts of data in short order. My hope is that the agencies in these countries agree. Perhaps the Phillipines or Brazil agrees, and we are able to treat a thousand people over a short period of time and give that data to the FDA.
In a normal world, they would require a new trial. But we are in a pandemic, and Janet Woodcock as made it crystal clear that statistical significance is not a requirement for an EUA.
Time will tell.
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