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.
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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.
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Even a disapproval allows the applicant to submit amendments. And the game of ping pong commences, until one or the other gives up.
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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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