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Investor2014

05/12/23 11:59 AM

#415059 RE: abew4me #415057

This is incorrect and shows you have not read or understood my posts and clear examples.

“The only confirmatory trial that allows a company to commercialize their product is a P4 trial.”
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Joseph_K

05/12/23 12:34 PM

#415075 RE: abew4me #415057

This is incorrect:

The only confirmatory trial that allows a company to commercialize their product is a P4 trial.


You're not understanding how Accelerated Approval works. You get approval to sell your drug, but it can be revoked if the FDA is dissatisfied with the ensuing P3. Again, consider the AA approval for Leqembi (plus Investor's links).