(I believe) There will be NO CR ahead of FDA (likely) approval of kids aGVHD product. MSB has just enough funds [and access to funding (borrowing) sources] to get them that far down the road. Obviously, an inevitable CR AFTER kids approval, is a vastly better proposition, for everyone!
I thought today's update, whilst not startling in any way, was rather progressive.....as others note, the "domino effect" could be very real here.....keeping your eye on the heart space is truly eye-popping in potential!!!
I continue to be wary of the FDA, but certainly their language is much more upbeat this time around....(not much more) time will tell!
Key takeaways:
- more engaged FDA
- FDA open-minded to heart space progress
- anticipated product pricing-points look very rewarding
All IMO, DYOR.
Ann: Annual Financial Results Presentation, page-17
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