Wednesday, October 24, 2018 9:15:07 AM
If denied BTD, then yes the BP would then be inclined to wait for the outcome of the FDA EOP2 meeting, to get more color on the FDA's views on the conventional clinical development.
It's good to see that we were granted the EOP2 meeting. But while those meetings are not always a given, it's not much of a surprise for us (B is a Fast-Track drug after all).
Helpful, straight from the FDA:
https://www.fda.gov/downloads/Drugs/Guidances/UCM358301.pdf
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