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3X Charm

07/16/21 1:04 PM

#174661 RE: Yki #174657

You equate an RTF on the BLA a success? Maybe in NP world.

FYI , Less than 4 % of drug filings get an RTF. NP is just so special.

The percentage of RTF’s are low because knowledgeable pharma executives listen to what the FDA tells them in crafting a BLA or pull it based on what they are being told during the review. Neither event occurred here, so illustrious leader NP evoked this “ special treatment “ for CYDY HIV BLA.

To be clear simply resubmitting the deficient dosing and RO info is not a milestone …. Maybe for NP, since he has no other achievements.