Ann: Update on Scheduled FDA Advisory Committee Meeting, page-46

I think they meant ‘Provides’ because until now, Who did they provide the update to? certainly wasn’t the market. They should have had a market announcement ready to be put out when the submitted their doc to ODAC site.
I think today has seen a massive and unsubstantiated negative overreaction to FDA docs uploaded which may have been lessened by the company having this notice out this morning, and not near end of day.

I didn’t see anything to ring alarm bells in the FDA docs.
The FDA acknowledged The latest MSB trial proved efficacy!
Noted lack of efficacy in the old pre-MSB trials which most SH should already be aware of. These where 10yrs ago! FDA has questioned the relavence of these old studies, which to me is a positive if they can justify that they are outdated and don’t represent the improved MSC treatment put forward by MSB in the latest trial.

If the old studies are discounted then what’s left it’s a safe treatment with proven efficacy.
MSB and the ODAC panel then discuss and decide if single arm study was sufficiently robust to warrant approval on its own.

Worst case I see, is they recommend a other trial.