So, from the quarterly report :
Manufacturing inspection complete over 10 days with no serious issues discovered. Final report due in a couple weeks ( probably with mid cycle review notes ), I think my prediction of by end 1st week June is looking to be accurate.
Apart from that only labelling discussions remain with the FDA, before PDUFA.
Possibly a CIBMTR or NIH partnership to help fund expansion into adults, or using existing debt, or a finance royalty scheme directly after approval.
CLBP trial product already manufactured. Enrolment starting in Q3, along with FDA meeting on Potency assays for CLBP - still including 20% Europeans for Grunenthal considerations.
CHF meeting sounds like it has not yet occurred, so still ahead at some point, or possibly the result of the meeting has not been reached.
All in all, countdown to lift off still on track ! No manufacturing show stoppers.
2023 The Final Countdown, page-420
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