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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