Hi Maxine
You're right, and it seems a little odd that CDER (Drugs section)has granted approval for BTD to 26 out of 83 applications so far, yet CBER (Biologics and vaccines section) has knocked back 8 out of 10 (with 2 pending).
You're pretty well up on this stuff, have you got a theory for this apparent disparity?
prr could be blockbuster from 1 october, page-10
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