Replies to post #222406 on Elite Pharmaceuticals Inc (ELTP)

[Couch]

Yes, 2002 FDA guidance AS WELL AS 2014 specific statement to ELTP THAT IT WAS ONLY A LABELING ISSUE!!!!!!!!!!!!!

Indeed; and why Nasrat hired Eugene Pfeifer (see below)..... the man knows how to interact within the FDA system. Then you take the recent DD via WeeZuhl and one begins to see Nasrat, Eugene and Camargo have a lot to discuss with the FDA. They will carve out a path forward for SequestOx approval IMO.

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=124579915

Mr. Pfeifer brings with him more than 45 years of regulatory and trade experience, most recently having served as a law partner at King & Spalding in Washington DC and prior to that as a law partner at the Burditt, Bowles & Radzius. Among his many accomplishments, he was a major participant in the development of the Drug Price Competition and Patent Term Restoration Act of 1984, and provided strategic counseling to companies affected by that statue. In addition, he has provided regulatory advice and representation on a wide variety of FDA, FTC, and DEA regulated activities, including product approval, advertising, promotion, and compliance issues.

Prior to working at Burditt, Bowles and Radzius, Mr. Pfeifer served for a year in the General Counsel's office of the Federal Trade Commission, where he represented the FTC in Federal Court to enjoin violations of the Federal Trade Commission Act, and served ten years in the Chief Counsel's Office at the FDA as Associated Chief Counsel for Enforcement, Associate Chief Counsel for Drugs and Deputy Chief Counsel for Regulations and Hearings. During his tenure at the FDA, he was the FDA's lead litigator and Appellate Court advocate, and he briefed the FDA's cases before the Supreme Court. Mr. Pfeifer is a graduate of Brown University and the Georgetown University Law Center.

[dr_lowenstein]

Ah the crooked FDA excuse again. Lol