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Re: BonelessCat post# 246179

Wednesday, 10/24/2018 9:15:07 AM

Wednesday, October 24, 2018 9:15:07 AM

Post# of 403016
I'd caveat that last part. The most impact is the BTD verdict, whose 60-day response interval is independent of the EOP2 meeting. BTD holds tremendous value and shows the FDA's view of the drug's potential attractiveness and viability, so the BTD verdict, if positive, would be the BP's likely deal terms trigger. BTD is huge.

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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