Well.....
The only requirement for accepting the BLA, is that the company has responded to the items in the CRL.
They have indicated many times that they will address all items, so I think it's a done deal.
We won't know until March at the latest, if the FDA accept the responses and the treatment as a whole though...
I think the Share Price will go up, on the news that the CLBP trial has commenced... and the countdown clock to a block buster is running.
It provides a level of redundancy incase there are issues with the GvHD BLA.
So does CHF, ARDS and Crohns
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