This is how the FDA works. Pretty par for the course really. Its not bad news, anyone in biotech stocks knows there are a series of ongoing blocks to progress tossed up and that they demand more and more.
This is a first in class treatment, they are going to be doubly cautious.
MSB will get its approval soon, paving the way for the acceptance of stem cell therapies more broadly.
Ann: Update on BLA for Graft Versus Host Disease, page-51
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