I quite like the 97% odds to date Doc..but of course you know...

I quite like the 97% odds to date Doc..but of course you know best



https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10329213/




Remember Doc , according to the conference call, all the other boxes have been ticked relating to meeting primary endpoints , safety , manufacturing inspection etc., it is only the remaining CMC issues identified in the 2nd CRL which are still being scrutinised. The potency assay is the key remaining component and that has already been shown to the OTP in a Type C meeting in March this year as part of preparing protocols for the adult label extension. There is also labelling and post confirmatory commitments to be agreed . After getting the new potency assay data briefing The FDA told them to file for full paediatric approval and accelerated approval in two other conditions. Doesn’t sound like they want to turn the lights out just yet ! OP


Please do not rely on the facts or opinions contained in the above post when making an investment decision.