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mrwrn2010

08/01/23 12:15 PM

#383582 RE: kayak_wench #383580

This was my question as well, how do the approval timeframes work
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The ELTP King

08/01/23 12:20 PM

#383585 RE: kayak_wench #383580

Why did you REFUSE to read my post from 13 days ago?

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172381276

PDUFA date started several months ago.

Everything I am seeing on the internet indicates thatthe 10-month review clock under PDUFA starts from the date of the complete submission of the application, yet Nasrat said they submitted a partial application for the Oxycodone generic to get the PDUFA date going. Is this situation different because its not an initial submission rather a response to a deficiency in an earlier submission?

If it is 10 months from submission, it looks like we are looking at an approval early next year (if the full application is accepted...).