Elite Pharmaceuticals Inc (ELTP)

[imanjen13]

Perhaps someone can clear up the issue of the status of the Oxycontin submission.
Nasrat indicated that the company submitted the ablation study to the FDA to start the clock which is usually 10 months after the drug application is ACCEPTED or 6 months after is the drug is given priority review.
He also indicated that the final complete application will be filed before August 1, a mere 3 weeks hence and the FDA has 30-60 days to ACCEPT, the application.
Question. If the application is filed Aug 1 and is accepted by the FDA around October 1 is the earliest we can expect approval August 1, 2024 or was the PDUFA date set when the ablation study was submitted.
A response form anyone who is familiar with the ANDA FDA protocol will be appreciated.