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Posted On: 02/08/2021 11:32:55 AM
Post# of 148902
I agree, I hope they PR the results in a very CLEAR format, without any ambiguity (which as we all know, has been a challenge). But, if they do issue a PR about a CC, please for our sake, make it a day or two out MAX, not 5-7 days!
Question for the group...does the FDA have the ability or "power" to say "give us all of your data, but don't PR anything until we review it, and decide how to move forward"? And, if the data is unblinded, and it still takes two weeks for the topline report, is the unblinding a "material event" that needs to be PR'd?
Question for the group...does the FDA have the ability or "power" to say "give us all of your data, but don't PR anything until we review it, and decide how to move forward"? And, if the data is unblinded, and it still takes two weeks for the topline report, is the unblinding a "material event" that needs to be PR'd?
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