nothing is impossible, but it’s totally up to the FDA.
Although given that Mesoblast are the leaders in the field and the ODAC panel didn’t have anything that useful to add on manufacturing … I don’t think the FDA will see much value of another ODAC if it’s centred on manufacturing. The first one had one question only for the ODAC panel where they would publicly vote, and it was on efficacy. It was 9-1 for efficacy.
IMO if OTAT are comfortable with the assays, then that’s their own technical team giving them comfort.
but if they do another ODAC, with more data that has been already interrogated by OTAT… well the outcome can only be better for MSB and not worse. Which is why I don’t think the FDA will bother.
nothing is impossible, but it’s totally up to the FDA.Although...
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