Ah Moe !
Hey while I’ve got you here.
I’m thinking we get an answer on Friday US time
as to whether the evidence is enough to
be deemed a resubmission. Plus whether
it is Class 1 or Class 2.
My opinion - don’t give a stuff what the naysayers
are on about.
Friday - end of 14 day turnaround as stated by CBER
Class 1- 2 month reply
Class 2- 6 month reply
Insufficient evidence - going to hurt
But when you spend 9 and a half million to prove a point,
it’s probably a good point.
Reg
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