Hi @poolboy, I agree they seem to be taking an inordinately long time to process all things PAR related, and it makes me pretty cranky.
For me, given that there are no serious adverse events to investigate, it makes no sense. I can only conclude there may more going on here beneath the surface. They gave us Fast Track designation, after all, and that seemed to come out of the blue to me.
As for bending over backwards, PAR have no choice but to give the FDA everything they want, and not be antagonistic.
I believe pushing back got MSB into an ugly place.
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Hi @poolboy, I agree they seem to be taking an inordinately long...
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