Ryoncil: ODAC/FDA Meeting Discussion, page-1159

Perhaps confirmation bias but I am super confident

AM session - FDA concerns about potency however no one came up with options for better assays. So there is acknowledgement that its not a perfect system. One of the panel stated that you could gather more data/do more trials to try to find a better marker, but in a years time, you could still not know. MSB indicated they were committed to continue to analyse/gather data etc and continue to improve. The only suggestion made on improvements was transcriptome sequencing. So IMO, no show stoppers, probably a few post-marketing commitments

PM session - none of the clarifying questions from panel were towards the FDA questions - aside from the comment that FDA allowed single arm trial for ruxtolimb and what's the difference with MSB, and a couple of questions on why Dr Kurtzberg wouldn't be comfortable with a double blind trial. General agreement that the remestemcel works, is safe with most questions on durability of response, steroid weaning, etc.

Cant see any reason atm for any of the panel to vote against MSB.