Ann: FDA Advisory Committee Sets Review Date for Remestemcel-L, page-503

You called it dplane. Thanks for your viewpoint. The FDA has to critique the application and provide an impartial analysis.
You raise some very valid points in (1) and (2). Perhaps I am missing something but I still do not see that the relationship between Ryoncil and Rem-L as being "completely" intertwined. The decisions on approval and Rem-L uptake are separate.

The way I see it the scenario may play out as follows. Pls note I am a rookie when it comes to biotech and FDA approvals so those in the know are welcome to objectively correct and argue the pros/cons. In the meantime the SP will simply fluctuate.

	ODAC Review on 13 Aug.	FDA Application	Effect on Rem-L
1	Not Recommend	Chance to answer some or all of FDA questions via ODAC. If there are still concerns because ODAC has made a favourable recommendation, then it may be possible that the FDA decision is delayed. MSB still has time (I would say till end of Sept) to answer all FDA concerns before that decision is made. Obviously you want to address these ASAP.	I think that a non-approval of ODAC will not influence the uptake of Rem-L with respect to Covid. Remembering that Rem-L is currently permitted because there is no other cure. We simply have to wait for the statistical results to come through irrespective of FDA or ODAC approval on Ryoncil. If the results are positive then that may allay some of the risks. That said, more time may be required to evaluate longer time side-effects but hey if it saves a life short term, who knows what the decisions are going to be.
2	Recommend	Chance to improve and strengthen FDA's concerns to maximise the chance of approval.	It will be a huge win. Rem-L is likely to advance forward but I still stand to make the point that the long term effects are still unknown. Nonetheless as a last line of defense, Rem-L shows some positive outcomes. The sample size is still on 9/12 people so it is tiny - we just have to wait til the results come out.