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Re: boi568 post# 384215

Saturday, 11/19/2022 7:42:22 PM

Saturday, November 19, 2022 7:42:22 PM

Post# of 463925
It is a big hope and speculation that FDA will approve the drug based on just one P2/3 trial that has 3 arms - so even if the drug is successful it will be based results of only 160 odd patients as one dose trial is 1/3rd

In reality, the trial has not stopped in between due to some great results - so we can assume that the results are not that spectacular.

So FDA is unlikely to approve the drug based good or very result where the trial had not even locked dosing.

So FDA is most likely to ask for a large trial with before approval - people are suffering from AZ for years now so not approving the drug is not so bad. Waiting for additional results is worth for FDA
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