Here's Where The Upside Is Coming From For Elite Pharmaceuticals Inc (OTCMKTS:ELTP)

Elite Pharmaceuticals Inc (OTCMKTS:ELTP) is one we keep coming back to here at Insider Financial. Our regular readers will know it's a stock we've liked for a while, and one that we think has some real reward potential as a long term position. There have been a couple of outstanding questions related to one arm of its operations, however, and these questions have seemingly made wider markets reluctant to share our enthusiasm.Well, we got the answer to these questions mid last month, and just this week, Elite has put forward another announcement, lining up some near term catalysts.Here's what's happened, and what we're looking for going forward.This company is a biotech play with three distinct but probably equally important areas of operation. The first is your traditional development pipeline operation, as part of which Elite is trying to get a drug called SequestOx approved as an abuse deterrent oxycodone product (we'll come back to this shortly). The second is a generic drug manufacturing operation, which provides what we see as a sort of bread and butter type revenue stream that can help to foot the bill on the pipeline side of things. The third is a generic development pipeline operation, under which the company submits ANDAs to the FDA in an attempt to get marketing approval for generic versions of well established (and high selling) already approved drugs (again, we'll comeback to this shortly).So, the mid March development relates to SequestOx. Check out this piece for some detailed background. Basically, the FDA issued a CRL against the company's NDA submission last summer, and Elite has spent the better part of ten months trying to get a response together. It's taken a little longer than expected, but as per the announcement last month, there's now a trial underway that should serve to answer the concerns the agency has about the drug (the concerns are rooted in the potential for overdose when administered in and around mealtime). It's a quick turnaround study, and Elite expects to have data by May. A resubmission will follow almost immediately, and both this submission and a subsequent FDA decision are real catalyst to watch.The most recent announcement relates to an ANDA submission for a generic version of a synthetic narcotic analgesic indicated for the management of pain. Again, readers looking to catch up should check out this piece. Elite is trying to submit one of these types of applications every quarter, and there are now three in place with the FDA. The key thing to recognize with these submissions is that Elite isn’t going to (or even aiming to) capture a substantial portion of the market for each indication – it doesn’t need to. The markets it's looking at targeting are worth tens of millions or more in total, hundreds of millions in some instances, and Elite only needs to capture single digit percentage points from one to start bringing in multiples of its current revenues.So, this brings us to our second (or third, or fourth) potential catalyst – the FDA green lighting one of the outstanding ANDA submissions for commercialization. As mentioned, there are three in place right now, and between now and the end of the year Elite has stated it expects to submit one per quarter, which should bring the total to five or six. As the FDA responds on each, and there looks to be no reason why these responses shouldn’t be positive (the company has an established manufacturing facility and these are generic assets) the Elite's value should appreciate.As we've noted before, the potential for dilution is diminished somewhat on this one by the company's generic manufacturing operations and the revenues earned therein. It's not completely negated, however (chances are we'll see a raise ahead of the FDA's decision on SequestOx), so keep that in mind when considering a position.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.