This comes as a shock to many that Novartis pulled out of the collaboration. The timing couldn't come at the worse time as SI said the OTAT meeting was last month, most likely end of Nov. This meeting is extremely important because it address the potency assay and CMC items on Remestemcel-L for GVHD and ARDS implications. So the question is did Novartis found out the result of OTAT meeting from SI? Don't forget, Novartis didn't even pull out when Covid-19 ARDS results were announced. I don't see why Novartis would pull out before the formal minutes from OTAT meeting are released unless they know the outcome.
In the announcement, MSB will continue to initiate a confirmation phase 3 trial alone. Would they have enough capital to do it or would another CR is required?
OTAT Meeting
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