Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

How can this be true?


http://ir.elitepharma.com/profiles/investor/ResLibraryView.asp?ResLibraryID=74683&GoTopage=2&Category=2163&BzID=2258&t=1956&G=939

Elite Pharmaceuticals Reports Successful Pivotal Bioequivalence Study For Abuse Deterrent Product ELI-200

Northvale, New Jersey, Wednesday, March 05, 2014: Elite Pharmaceuticals, Inc. ("Elite" or the “Company") (OTCBB: ELTP) announced today successful results from a pivotal bioequivalence study initiated in January 2014 for Elite’s undisclosed abuse deterrent opioid product, ELI-200. The study results demonstrated Elite’s product is bioequivalent to the branded drug based on pharmacokinetic measures including peak concentration (Cmax) and area under the curve (AUC) for opioid blood plasma levels. The study was a single dose, open label, partially randomized, three-way cross over study in healthy volunteers with 42 subjects under fasted conditions and 38 subjects under fed conditions.

Based on what I heard on today's call, in 2014 Nasrat Hakim understood and discussed with the FDA that ELI-200 was NOT bioequivalent under fed conditions, specifically in regard to Tmax. He said today that he was advised in November 2014 in a meeting with the FDA that it would be a labeling issue. So he did not think it was an issue, but he did know it was not bioequivalent under fed conditions for Tmax.

In my opinion, the above statement in red is false. Also in my opinion, it is written in such a way as to weasel around the Tmax issue, but it is so poorly written that it fails in the objective and invalidates itself. Nasrat, this is why it pays to keep a good writer on staff.

Here's what they wanted to say, I added "the" and removed "including" and now it is a true but weasely statement:

The study results demonstrated Elite’s product is bioequivalent to the branded drug based on the pharmacokinetic measures peak concentration (Cmax) and area under the curve (AUC) for opioid blood plasma levels.



The way I wrote it, the bioequivalence only applies to Cmax and AUC and nothing else. The way they wrote it, the bioequivalence applies to all standard pharmakokinetic measures, including Cmax and AUC (and even though not specifically mentioned, Tmax). Two words are a subtle difference, but in this case they cause the ELTP PR from March 5, 2014 to be provably untrue.