For clarification as the PDF can fail to load. It took me 3 attempts to load it.
I think firstly that the document is non-binding on the FDA. So they do not HAVE to respond within 30 days. I would think that 30 days refers to federal employee working days, which would be the standard unless calendars days are specified.
The application can be approved, approved with condition, staged approval or disapproval. It has to be bad for a disapproval, assuming the claim that alternative treatments are not good, and or this is a novel therapy unlike anything else used before.
Even a disapproval allows the applicant to submit amendments. And the game of ping pong commences, until one or the other gives up.
Do we know if an IRB approval has occurred yet, or is it the intention to arrange this post an IDE approval?
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