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DewDiligence

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DewDiligence

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Re: dewophile post# 244860

Tuesday, 12/27/2022 6:27:45 PM

Tuesday, December 27, 2022 6:27:45 PM

Post# of 253393

RVNC—Is there a chance the FDA didn't accept the sBLA for CD yet? I don't see a PR from the company w a PDUFA date.

RVNC has not (yet) issued a PR confirming FDA's acceptance of the sBLA (for review), but that doesn't imply RVNC is getting an RTF letter. RVNC could simply be waiting until January to issue a PR containing not only the PDUFA date, but also some 2023 guidance (as many biotech companies do at the start of a new year).

An RTF is conceivable but is quite unlikely, IMO.

“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

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