There are no guarantees, but I would like to think like this...
aGVHD:
- FDA have been guiding Mesoblast through the whole long, arduous and costly process over many years
- FDA gave Mesoblast a rolling review, they had access to the data - so they could have said hey, you haven't got this or that
- FDA gave Mesoblast a priority review based on the same data
- Now scheduled an ODAC review date - based on the same data
- JCR Temcell has been used in Japan for a few years now without any safety concerns
You put the above together with a very high % of BLA that has a Priority Review, ends up with an approval.
I believe it is 80%-100%
So, there you have it...
There's a risk of the ODAC review being negative, but what is the probability of that happening?
My conclusion is it is unlikely for ODAC to provide a negative conclusion.
We are close to 100% over the line with Ryoncil - but, that's me - a glass very very full
MSB Trading - 2020, page-23083
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