@danzae - we are all in the dark.
We need more info, asap.
In the meantime, all we are doing is speculating on the possible scenarios.
I'm feeling similar to you, in that things did not add up.
Mesoblast doing a single arm study on GVHD is not new news to the FDA - so why has this made it all the way to BLA, Priority Review and ODAC review?
Personally, I'm just hanging my hat on the CRL is just the FDA pushing MSB to apply for the Accelerated Pathway.
We don't really know what get discussed behind closed doors, but atm we are all just waiting - arghhhhh more waiting
Bring on the Type A meeting request and the meeting itself - we need some light to be shed on this situation asap!
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