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Re: CalMustang post# 196428

Wednesday, 06/12/2019 6:19:51 PM

Wednesday, June 12, 2019 6:19:51 PM

Post# of 426265
Cal,

I honestly thought that the 74 day letter gave the FDA's "intention" whether or not that they were leaning towards an adcom. Sure seemed worded that way in the pdufa guidelines.
I was definitely with BB expecting a PR today regarding no adcom based on the information I found and others posted regarding the 74 day letter. Who knows.
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