Replies to post #239979 on Biotech Values

[Biowatch]

RVNC “unanticipated” ???

“are seeking further clarity from the agency”

That is good. You’ve had from June or July to seek guidance.

Please give your QA department all the authority and information they need to make sure you dot the i’s and cross the t’s.

[DewDiligence]

Re: RVNC CRL

Daxi approval is now a late-2022/early-2023 event, at best. The additional wait is painful because RVNC’s cash burn is high, making another capital raise all but inevitable. For a biotech investor, today’s news is about as bad as it gets.

Nevertheless, I’m holding all of my shares because CMC problems are fixable and I’m confident Daxi will eventually be a big-selling drug. I’m not planning to add, at least for the time being.