MSB Trading 2020 - a new dawn, page-548

I agree with you entirely on the importance of the ODAC outcome to the macro-narrative. I was trying to thread the needle between cautioning about the short-term (+5 day) SP based on SR-aGVHD market, while also acknowledging the huge potential in the long term in other applications.

ODAC effectively endorsed the MOA for Remestemcel-L, and FDA approval would cement that endorsement. My understanding is that is a huge step for a novel therapy with multiple potential applications because an application for a label extension will not face the same degree of MOA-related scrutiny as the initial application for approval (i.e. positive outcomes from clinical trials are more quickly and efficiently translated into label extensions than approvals for novel therapies).