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boi568

05/09/23 7:45 AM

#414396 RE: WolfofMia #414391

I read that as a confirming P4.

BAR123

05/09/23 7:46 AM

#414398 RE: WolfofMia #414391

So maybe what we are reading is that they have had discussions with the FDA or other agencies and they guided to a P4 confirmatory trial. and once they have the full data set ready for discussions with regulatory agencies, they will look for Accelerated Approval Pathway.

bas2020

05/09/23 7:49 AM

#414402 RE: WolfofMia #414391

Or confirmatory P4.
P3s are typically not referred to as "confirmatory".