Good conversation here on this.
I am a holder, believe in the tech etc (ie not a downramper) but I count this as a miss TBH and another example of miscommunication from SI implying there was finality to the BLA submission in that quarter, whereas now we learn there is a bit more too it ableit heading in a positive direction. Not sure why he'd be so definitive when you are at the mercy of the FDA on timeline ... but that has been a persistent flaw, one that will be forgiven when approval is granted.
Anyway, bottom line is market seems to love it - question to your learned ladies and gents is why?
Ann: Submits New Information to FDA IND File for SR-aGVHD, page-264
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