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Sunday, January 17, 2016 10:22:21 PM
In reality I think he was talking about the application for the filing itself. The FDA has given a 6-12 week acceptance window for the filing.
Being that this is the first filing for Elite that is probably why the fee was waived. $2.3 million is $2,3 million (big smile).
BTW I was wrong about the INDA. Even though this was filed with the FDA before the testings started it does not mean that the FDA was kept in the loop with data generated during testing.
It does give the FDA the opportunity to assist Elite in guidance
criteria it may like to see in the testing procedure.
The FDA ultimately reviews the data in the 505(b)2 filing as I understand it, which they are now doing.
Maybe Elite does go the full 6 month route. Maybe not.
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