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DewDiligence

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DewDiligence

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Re: jmkobers post# 239991

Friday, 10/15/2021 7:32:48 PM

Friday, October 15, 2021 7:32:48 PM

Post# of 252412

What do see now you didn't see 2 days ago?

The CRL means that the FDA is not satisfied with RVNC’s reply to the 483 deficiencies. After meeting with the FDA to obtain additional feedback (as stated in today’s PR), RVNC will have to fix the remaining problems and resubmit the BLA, which will start a 6-month clock for the FDA to render a decision.

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

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