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Alias Born 02/14/2018

Re: None

Wednesday, 01/23/2019 4:13:27 PM

Wednesday, January 23, 2019 4:13:27 PM

Post# of 108192
This nightmare never ends. Strange hold by the fda nonetheless.

FDA’s review of the AXAL Investigational New Drug (IND) application was prompted by our proposal to modify the AIM2CERV trial’s analysis plan

I wonder whats new that they found after already reviewing it prior. Maybe we should have just left the trial design as is.
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