Does anyone know if NDA is brought forward by the FDA in spite of the lawsuit and issues a tentative approval by September 25th - I would assume so... after all a law suit is not a proof of ineligibility.
Well no one responded... but I assume from the phrasing below that IPCI can/may get tentative approvalon September 25th with FINAL APPROVAL once lawsuit is settled... if not settled by then.
By reason of the commencement of these legal proceedings, the FDA is stayed for 30 months from granting final approvalto the Company’s RexistaTM abuse-deterrent oxycodone. That time period commenced on February 24, 2017, when the plaintiffs were notified of the Company certification concerning the patents, and will expire on August 24, 2019, unless the stay is earlier terminated by a final declaration of the courts that the patents are invalid, or are not infringed, or the matter is otherwise settled among the parties.