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Tuesday, 09/06/2022 10:23:34 AM

Tuesday, September 06, 2022 10:23:34 AM

Post# of 401441
Funny but not ha ha funny...

NORTHVALE, N.J., May 22, 2017 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCBB:ELTP), today announced the acquisition of an approved and currently marketed Abbreviated New Drug Application ("ANDA") for Trimipramine Maleate Capsules ("Trimipramine") 25, 50 and 100 mg, from Mikah Pharma, LLC ("Mikah"). Dr. Reddy's Laboratories, Inc. ("Dr. Reddy") (BSE:500124), (NSE:DRREDDY), (NYSE:RDY) will market and sell the Trimipramine products. Epic Pharma will manufacture the products under current agreements with Mikah. Eilte will assume these agreements with the acquisition of the products.



While the Elite Annual Report stated from 2015-2018 that Mikah had ceased operations, Mikah purchased the trimipramine ANDA sometime prior to July 27, 2016. Mikah made an agreement with Epic to manufacture and Dr. Reddy to distribute on May 4, 2017. Mikah then sold the ANDA to Elite just two weeks later, leaving Elite in an odd position of having plenty of manufacturing capacity but paying Epic to do the job. There was never any mention that I recall of seeking any kind board or shareholder approval for this CEO self-deal. It would have been very easy for a neutral third party to look at the receipts of divestiture sale price and revenue history and establish a fair price for both sides. Obviously, that didn't happen. The burden most certainly falls on Nasrat Hakim to prove beyond a shadow of a doubt that the deal was a good one for Elite shareholders, and I don't believe he made any effort at all to fulfill his obligation to me and every other shareholder.

https://www.ftc.gov/news-events/news/press-releases/2016/07/ftc-requires-teva-divest-over-75-generic-drugs-settle-competition-concerns-related-its-acquisition

https://www.sec.gov/Archives/edgar/data/1053369/000114420417032547/v468485_ex10-55.htm


This agreement insures the uninterrupted supply of generic Trimipramine. ... The ANDA purchased by Elite is currently the only marketed generic Trimipramine product.



Translation: every other manufacturer has had the good sense to discontinue this anachronistic highly-anticholinergic drug. If we would do the same, then the handful of unfortunate people still taking it would all be switched to something better and safer, and they would all be better off for it. This is not the kind of exclusivity that a generic manufacturer is hoping for.

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