FDA Waiver Is Just The Start For Elite Pharmaceuticals Inc (OTCMKTS:ELTP)

Elite Pharmaceuticals Inc (OTCMKTS:ELTP) is one OTC stock that we think every penny stock investor needs to keep an eye on. The reason being is that we don't think ELTP will be on the OTC markets for much longer. The company will either uplist to NASDAQ or it will get bought it. In all likelihood, we think ELTP is a takeover candidate for a big pharma company.ELTP is at the forefront of of the ADT opioid boom. Elite Pharmaceuticals is developing a pipeline of proprietary pharmacological abuse-deterrent opioid products as well as niche generic products. Elite specializes in oral sustained and controlled release drug products which have high barriers to entry. Elite owns generic and OTC products which have been licensed to TAGI Pharma, Epic Pharma and Valeant Pharmaceuticals International. Elite currently has eight commercial products being sold, additional approved products pending manufacturing site transfer and a product under review pending approval by the FDA.Elite’s lead pipeline products include abuse-deterrent opioids which utilize the company’s patented proprietary technology and a once-daily opioid. These products include sustained release oral formulations of opioids for the treatment of chronic pain. These formulations are intended to address two major limitations of existing oral opioids: the provision of consistent relief of baseline pain levels and deterrence of potential opioid abuse. Elite also provides contract manufacturing for Ascend Laboratories (a subsidiary of Alkem Laboratories Ltd.), and a Hong Kong based company for development of a branded product for the United States market and its territories. Elite operates a GMP and DEA registered facility for research, development, and manufacturing located in Northvale, NJ.Elite’s proprietary abuse deterrent technology, ART™, is a multi-particulate capsule which contains an opioid agonist in addition to naltrexone, an opioid antagonist used primarily in the management of alcohol dependence and opioid dependence. When this product is taken as intended, the naltrexone is designed to pass through the body unreleased while the opioid agonist releases as intended providing therapeutic pain relief for which it is prescribed. If the multi-particulate beads are crushed or dissolved, the opioid antagonist is designed to release and so block the effects of active opioid agonist. The absorption of the naltrexone is intended to block the euphoria by preferentially binding to the same receptors in the brain as the opioid agonist and thereby reducing the incentive for abuse or misuse by recreational drug abusers.Elite’s pharmacological approach to abuse-deterrence can be applied to a wide range of opioids used today in pain management. The key here is that most physicians think opioid antagonists is the abuse-deterrent formulation that is most needed to combat the opioid abuse epidemic–an issue that’s been implicated in the startling rise of the death rate of middle-aged white Americans without a college degree. This painkiller addiction has a big impact on America as there are an estimated 44 deaths per day from prescription painkiller abuse. This has become a major problem and why advances by ELTP are so important to solving this opioid epidemic.

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Elite was just notified by the FDA that the company has been granted a waiver of the application fee required for the filing of a New Drug Application (NDA). Under section 736(d)(1)(E) of the Federal Food, Drug and Cosmetic Act the FDA may grant a waiver of the $2,335,200 NDA application fee for the first human drug application that a small business submits for review. Elite will immediately submit a 505(b)(2) New Drug Application for its lead opioid abuse-deterrent candidate ELI-200, immediate-release Oxycodone Hydrochloride 5mg, 10mg, 15 mg, 20 mg and 30mg capsules with sequestered Naltrexone Hydrochloride, for the treatment of moderate to severe pain with the United States Food and Drug Administration. FDA notification regarding acceptance of the submission for review is expected to take 6 to 12 weeks. As CEO Nasrat Hakim said:

"Having the FDA waive the application fee is a huge benefit to Elite. We will file the ELI-200 submission immediately. I look forward to hearing from the FDA concerning a notification of the acceptance for review in the coming weeks."

We think this is just the start for Elite. We expect to see 2 to 3 more NDAs this year. We’ll at least see NDAs for ELI-201, ELI-202, and possibly ELI-216. Why we think this will happen is because of acceptance by not only physicians, but also from insurance companies to cover ADT opioids. Both will benefit from wrongful death lawsuits and we see Federal and State agencies getting behind the push towards ADT opioids. It’s a major problem in America and ELTP is at the forefront of this problem. Matter of fact, ELTP is the solution to the problem!

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We think 2016 will be a big one for ELTP. ELTP is one of the very few companies on the OTC markets that has the potential to be a 10-bagger with the potential of its new drugs. ELTP is also a serious candidate to be bought out by a big pharma company looking to be at the forefront of the ADT opioid boom. We will be updating our subscribers as soon as we know more on ELTP. Be sure to sign up and don’t miss out on the latest on ELTP!Disclosure: We have no position in ELTP either long or short. We have not been compensated for this article.