Elite Pharmaceuticals Inc (ELTP)

[kayak_wench]

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...).