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Here's A Theory About The Latest Elite Pharmaceuticals Inc (OTCMKTS:ELTP) Release

Here's A Theory About The Latest Elite Pharmaceuticals Inc (OTCMKTS:ELTP) Release
Written by
Chris Sandburg
Published on
May 23, 2017
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Back on May 10, we published this piece asking the question: Is The Elite Pharmaceuticals Inc (OTCMKTS:ELTP) Data About To Hit Press?The data we were referring to was from a bioequivalent study of its lead development outside, an abuse-deterrent opioid called SequestOx. To quickly bring readers up-to-date, the company submitted an application last year to the FDA for approval of this asset but received a complete response letter (CRL) subsequent to the submission. Management sat down with the FDA after the CRL was issued and the agency outlined the necessity for a bioequivalence study to address potential safety concerns associated with overdose potential. The bioequivalence study kicked off late first quarter and data from the study is set to hit press any day now.When the company put out a press release after hours on Monday, therefore, markets initially got pretty excited. This excitement quickly abated, however, with the realization that the press release detailed the acquisition of an already approved ANDA associated with a drug called Trimipramine Maleate, which is a generic form of Surmontil, a tricyclic antidepressant.The question now is, what does all this mean?Well, taken in and of itself, the Trimipramine announcement is sort of neither here nor there. The drug is a generic antidepressant with a market of around $2 million in the US, and when the marketing and manufacturing arrangements associated with the company's acquisition of the ANDA are taken into account, it's not going to mean more than low triple digit thousands of dollars' net income addition for Elite annually. That's better than nothing, of course, but for shareholders who were waiting eagerly to see if data from an ongoing study supported the approval of a drug potentially worth hundreds of millions of dollars, it's small fry.It's not all bad, however.The arrangement brings with it a relationship with drug developer/manufacturer Dr. Reddy’s Laboratories, Inc., and there is room for this relationship to benefit Elite and its portfolio of approved and pending generic applications going forward – Trimipramine aside.There is also a question that could be asked as to why the company put out the release when it did.Elite publishes its press releases at or before market open, with practically no exception. The only instance this author can recall that bucks this trend was the announcing of the above mentioned Complete Response Letter, which hit press after close on Friday, so it sort of exempts itself from standard activity. The latest release hit press post-close on Monday. It's not a breaking release and it's (as we've noted) not all that important in the grand scheme of things. To support this statement, the company is essentially flat on its pre-announcement price heading into the session start on Tuesday.The only way that the release of this announcement coming after market close on Monday makes sense is if management already planned to put out the data from the above-discussed bioequivalence study at market open on Tuesday and wanted to squeeze in the news about the Trimipramine acquisition before the bioequivalence data hit press. Perhaps management wants shareholders to focus on the data as opposed to the acquisition and didn't want to release the two developments at the same time.This is, of course, highly speculative. There's no guarantee that we are going to see the bioequivalence data hit press today, or this week for that matter. With that said, we know it is scheduled for reporting mid-May, and that puts right about now as a clear target period for distribution.If we do see the data hit press today, and it's positive (for those new to this one, positive will be if the numbers show that the reformulated version of SequestOx has a shorter Tmax under fed conditions), then the company is going to take off.We will be updating our subscribers as soon as we know more. For the latest updates on ELTP, sign up below!Disclosure: We have no position in ELTP and have not been compensated for this article.

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