December 31 2023- Company advises they have generated the potency data requested by the FDA. ie we have answered the CRL
February 29 2024- Company advised new potency assay data was with the FDA and a follow up meeting scheduled
March 26th 2024- The FDA responds to the potency data provided , which the company prepared specifically in answer to the CRL.
So the potency data was with the FDA for a month. They checked it to see whether it answered the problems specifically raised in the CRL.
If it didn't answer the CRL then they would have received a negative reply.
Instead the company released a statement saying the FDA NOTIFIES MESOBLAST
THAT AVAILABLE CLINICAL DATA FROM PHASE 3 TRIAL APPEAR SUFFICIENT TO
SUPPORT BLA SUBMISSION FOR REMESTEMCEL-L IN CHILDREN WITH STEROIDREFRACTORY ACUTE GRAFT VERSUS HOST DISEASE (SR-aGVHD)
They don't say the potency data is sufficient- but they may as well have. We are not being told to proceed because the data is crap, rather- spectacularly- it answers the CRL.
This stock is now about dollars not cents.
Safety/Efficacy/Manufacturing and now presumably potency is done and dusted.
The company has never been in a better position
ever
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- 2024 Here we go again.
2024 Here we go again., page-386
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