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Posted On: 01/26/2021 9:17:47 PM
Post# of 155039
Re: Cassandra X #74531
Great explanation. And matches up mostly to what we've speculated. With a few exceptions.
Part of the challenge with figuring out timing is that all of the information we can find about the processes are pre pandemic processes. Some things have been streamlined.
Pre pandemic, the process was as you described. I think it's plausible that currently there .ay be some ways to get the data processed sooner.
And, I know many people disagree with me, but I believe that the FDA has the authority to talk to the DSMC and even request data from them. There is no reason for the FDA to be blinded to anything in an emergency situation.
Doesn't mean they did get any data. Just saying they could.
Part of the challenge with figuring out timing is that all of the information we can find about the processes are pre pandemic processes. Some things have been streamlined.
Pre pandemic, the process was as you described. I think it's plausible that currently there .ay be some ways to get the data processed sooner.
And, I know many people disagree with me, but I believe that the FDA has the authority to talk to the DSMC and even request data from them. There is no reason for the FDA to be blinded to anything in an emergency situation.
Doesn't mean they did get any data. Just saying they could.
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