MSB vs CRL, page-33

A CRL is a possible outcome. Put aside confirmation bias and think of the likely outcomes.

That MSB has filed a BLA, which leaves the FDA to provide ODAC such serious questions of Rynocil - inability to get comfort around CQA (a potential platform killer), MOA, trial design, past failures, and a hint that it would prefer to see it work in adults first before giving it to children, does not say they are ready with the approval stamp and ribbon cutting ceremony.

This original post raises a very serious point.


I sold when I read the FDAs discussion points for ODAC. I had held MSB for many years prior.

I do hope MSB can overcome it but hope is not in my investment thesis for MSB.

Without attacking me, happy for someone to distill there is more than hope, quoting from the FDA commentary to ODAC.

Thank you.