Ann: FDA Advisory Committee Sets Review Date for Remestemcel-L, page-604

Some further thoughts relating to the imminent approval:

I have looked at the FDA's press releases over the last 3 months and have found that, out of 17 treatment/device approvals, 10 (around 60%) were released on a Thursday or Friday. Interestingly, one for an EUA was released on a Sunday! So there is a very good chance we might hear about the approval via FDA press release on Friday/Saturday either next week or the week after. Given the time differences, we will likely know before MSB releases information to the market the next market day.

Further evidence of a likely approval is that FDA themselves provided the following statements to the ODAC meeting:

"Protocol MSB-GVHD001 met its primary objective; the Day-28 ORR was 69.1% (95% CI: 55.2, 80.9) in the FAS. The primary endpoint results in MSB-GVHD001 were statistically significant, the measured response was durable (median 54 days), and the results were consistent across subpopulations and secondary efficacy endpoints.

In general, no safety signal of concern was identified in the studies of remestemcel-L."

IMO, FDA were aware that ODAC members were experts on drugs for cancer treatment and not on MSC treatments, so they presented some very challenging information to ODAC to force them to consider important details of manufacturing, quality, consistency, mode of action etc before voting. By doing this, a more informed ODAC vote means there is less pressure on / criticism of FDA when approval is finally given.