30 straight days, if no word. The IDE is approved.
The FDA can approve/deny anytime before the 30 day deadline.
Which I believe most are thinking it’ll get approved before hand because of the BDD and the EFS IDE route.
BDD gets expedited reviews, and the EFS route is pretty much the FDA held the company hand and told them exactly what test and what the parameters needed to be for each test. So in short majority of the data has been reviewed by the FDA already.
IF we HEAR form the FDA is means the are having problems approving it, IF IF IFN at the end of the 30 days we have heard NOTHING, we are then and only then GOOD TO GO and move forward is the way I understand it
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