Hey Southoz ... what’s the rationale / motivation of the consultants (experien I think) in these situations ?
Do you think they would recommend submission if they thought low chance or not?
Or is it because they assume it might get rejected, but rejected with advise to do x, y or z and then you will obtain approval? (So gathering information for second attempt)
Many thx
Ann: ResApp Submits De Novo Application to the FDA, page-80
Currently unlisted. Proposed listing date: 4 SEPTEMBER 2024 #
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