.... you have not, still spreading disinformation like wildfire.
Si literally just told everyone this just over 9 weeks ago.
"I am very pleased that our Biologics License Application (BLA) resubmission for approval of Ryoncil®
(remestemcel-L) in the treatment of children with steroid-refractory acute graft versus host disease
(SR-aGVHD) was accepted by the FDA. We are in active discussions with the agency and anticipate a
decision prior to or on the Prescription Drug User Fee Act (PDUFA) goal date of January 7, 2025"
Every company, that has ever submitted a BLA in the history of BLA's has expected the FDA to make a decision on or prior to their goal date. That is the definition of a goal date. I can't believe I need to activate one of my superior brains cells to argue this point.
If you want some credibility - go do a statistical analysis of all company BLAs, and summarize % of them in 2022/23 were approved prior to the goal date.
I would then say MSB has that same % chance of getting approved prior to Jan 7th.
Hint - the number is low.
No approval Nov 22 does not mean never approved.
Your welcome.
Hint number 2....... I think the company may use approval Jan 7th to capital raise - just like BOT did. They may not technically need to because of the loan covenants, but they will be running low on cash by then, and if they want to manufacture serious amounts and get Adult trial running, and support CLBP, and support CHF accelerated approval ...... they would be better off doing it well funded.
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.... you have not, still spreading disinformation like...
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