About time and exciting isn't it @stockrock
"If the FDA accept this BLA resubmission, they essentially absolve this recommendation and agree to consider approval on the new data generated from the phase 3 trial."
Yep - agreed, but I'll go one step further - Mesoblast has been in dialogue and received guidance from the FDA - surely, this item would have been discussed and there would have been an in principle agreement between the FDA and Mesoblast - otherwise, why risk this one chance to do the Ryoncil BLA Resubmission?
I'm pretty confident that things will go smoothly and quickly from here in
It has been a horrid 2+ years since the CRL.
Finally, I'm starting to lift my head out of the dog house now
Ann: Mesoblast Completes Resubmission of BLA to FDA for SR-aGVHD, page-60
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