Can anyone confidently and exhaustively explain who likely adjudicated on the most recent MSB decision at the FDA and who would likely do so in a type A meeting?
I am presuming the Center for Biologics Evaluation and Research (CBER) was responsible but who within it oversaw the final decision and who might review a type A meeting? Plenty of subjective opinions on here on the FDA's processes but I've not seen any talk on this subject. Surely its crucial to the likelihood of success. The FDA has 15,000 staff and a vast array of procedures and protocols. Its not like all decisions simply go to the top, there are all sorts of different departments, advisory panels of experts etc.
I've researched this but its just not clear. Appreciate any advice...
MSB to dispute FDA finding in Type A meeting, page-471
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