'Cafa Where did you get the 45 days from? It is 30 days according to this link.'
Now you have let the cat out of the bag My bad.
However it is interesting that none of the +ve folks picked up on this. Do they not know?
If I had serious coin at stake I'd make it my business to know that is for sure!
FDA will notify the sponsor via email of the date it receives an IDE application. FDA may approve, approve with modification, or disapprove an IDE application. FDA may request additional information about an investigation.
We have to assume that an approval, or an approval with modification, would have been telegraphed to the ASX by now. It does look on balance that a disapproval was made or additional information has been sought,.
The sponsor may provide the requested information or the sponsor may treat such a request as a disapproval of the application and request a hearing in accordance with 21 CFR 16.
One has to assume that the additional information is being worked on, currently. I'm not sure what time scales the FDA are committed to once the game of ping pong commences, which looks as it this is the case. Could be quick, or not.
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My bad.
(20min delay)