THIS IS WHAT YOU NEED TO KNOW BEFORE CONSIDERING TO BUY ELTP ****Read the Company's website, look at what has come before Nasrat became CEO, understand who Nasrat is and where he came from, read the company's PR's and SEC filings, and listen to the various presentations the company has been a part of. I'll provide just a few. The learning curve is steep but if it is worth the going it is worth the travel. http://www.elitepharma.com http://www.elitepharma.com/management-key-employees/ http://b2icontent.irpass.cc/2258/166192.pdf
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After this light reading, I'll present a few thoughts with FACTS/LINKS on the present backdrop of Elite and why I believe this is a great company to invest in. 1) There are ZERO IR ADT opioids on the market with an ADT label. ZERO
This represents a HUGE market for Elite both in relation to SequestOx but also in relation to Elite's ADT generic pipeline. More on this later.
There are currently NO immediate-release with FDA-approved AD labeling consistent with the 2015 guidance for industry, “Abuse-Deterrent Opioids — Evaluation and Labeling.” There also are no currently approved generic versions of opioids with approved AD labeling.
2) The FDA is pushing for all opioids to one day be abuse deterrent opioids. Abuse-Deterrent Opioids: What You Need to Know http://www.medscape.com/viewarticle/867679_2
The FDA looks forward to the day, hopefully soon, when most opioids in the United States are marketed in abuse-deterrent forms. To facilitate an open dialogue on this important issue, and to obtain clinical and scientific input from outside experts, the FDA plans to hold a public meeting in November to discuss issues related to the development and evaluation of abuse-deterrent technologies, particularly for generic drugs
3) 90% of all opioids prescribed are immediate release opioids. Notice the head of the FDA has also stated that he hopes one day all opioids are abuse deterrent opioids. Further, the FDA has become more serious about thwarting abuse of opioids part of doing so is pushing the development of ADT opioids such as Elite's phramacologic approach. You might also notice that 90% of all opioids prescribed are immediate release but also that 90% of all opioids that are prescribed are generic brands. To move forward there are also zero generic drugs that are ADT on the market.
FDA requires 'black box' warning on painkillers http://www.cnn.com/2016/03/22/health/fda-opioid-black-box-warning/
Califf said he hoped that all opioids would eventually be abuse-deterrent versions, but he cautioned that there's still research needed about how effective they are in the real world.
4) In March of 2016, the FDA came out with required labeling changes for Immediate Release opioids including additional warnings and safety information that are expected to be incorporated. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm491739.htm
Unfortunately, Elite's SequestOx's NDA was already filed with the FDA or Elite would've been able to receive additional guidance from the FDA on how to incorporate these changes. This highlights how a change in policy though well intentioned can have adverse effects or a ripple effect in the industry on specific companies prior to the new changes being put in place. IMO Elite was a company caught in the aftermath of this focus by the FDA on immediate release drugs. For instance, the TMax issue was previously seen as a labeling issue by the FDA then became a safety issue that all immediate release products have. 5) IMO because the TMax issue is not limited to Elite, I do believe the FDA is going to find it necessary to offer companies like Elite a way forward to contend with the heavy meal TMax delay in regard to immediate release drugs. Again, remember the FDA is pushing for the eventuality of all opioids, immediate release included, to contain some aspects of abuse deterrent technology. Thus, it is a little disquieting to learn that in 2002 the FDA already had a way of dealing with the heavy meal TMax issue in immediate relaese drugs. It just so happens to be the exact approach Nasrat offered the FDA prior to commencing it's Phase 3 trial. Sprinkling SequestOx on applesauce prior to a heavy meal. Remember SequestOx is BE during non fed and highly fed conditions. Quiet shocking to investors to say the least to learn the FDA said the TMax issue was a labeling issue in 2014 and that Nasrat did not need to run the heavy meal arm of the Phase 3 to the FDA changing its mind in 2016 when it already gave guidance in 2002. The same guidance Nasrat offered to use but told it would not be necessary.
Guidance for Industry
Food-Effect Bioavailability and Fed Bioequivalence Studies http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126833.pdf
VI. OTHER CONSIDERATIONS A. Sprinkles
In NDAs, the labeling of certain drug products (e.g., controlled-release capsules containing beads) can recommend that the product be sprinkled on soft foods, such as applesauce, and swallowed without chewing. For the labeling to indicate that the drug product can be sprinkled on soft foods, additional in vivo relative BA studies should be performed by sprinkling the product on the soft foods to be listed in the labeling (test treatment) and comparing it to the product administered in the intact form (reference treatment), then administering both on an empty stomach.
6) Just to reiterate Elite's ADT can be applied to IR drugs - again which no IR drug on the market has captured an ADT label....SequestOx could be the first and only....and Elite's ADT can be applied to generic drugs -- of which there are ZERO generic drugs on the market that contain ADT period.
7) Elite has the ability to RIDE the GENERIC train via PFIZER - these Elite products will be the GENERIC and NDA's related to PFE's Embeda and Troxyca - AS NASRAT has stated Elite will save 30/70 million dollars in trials on Troxyca alone.
8) Nasrat understands what he is up against getting SequestOx approved and his chances are solid - over 75% depending on how you look at it. Notice that he has already prepped himself for the upcoming Type A meeting with the FDA as well.
The total approval rate jumped nearly 20% to 74.6% after companies submitted responses to the US Food and Drug Administration's (FDA) CRLs. A third round of responses brought that percentage up an additional 8.3% to 82.9%. - See more at: www.raps.org/focus-online/news/news-article-view/article/1138/bio-analysis-resubmissions-after-third-round-of-fda-review-not-worth-the-effort.aspx#sthash.ITXRWAim.dpuf
MEETING PACKAGE CONTENT AND SUBMISSION
Premeeting preparation is critical for achieving a productive discussion or exchange of
368 information. Preparing the meeting package should help the requester focus on describing its
369 principal areas of interest. The meeting package should provide information relevant to the
370 discussion topics and enable the FDA to prepare adequately for the meeting. In addition, the
371 timely submission of the meeting package is important for ensuring that there is sufficient time
372 for meeting preparation, accommodating adjustments to the meeting agenda, and accommodating
373 appropriate preliminary responses to meeting questions.
Quote: We met Camargo and other consultants and are in process of preparing a package for the FDA shortly requesting a type A meeting. The process is a little complicated and it takes time. You first have to send a letter to the FDA requesting a meeting, once they grant a meeting and give you a date, you need to send them a package with all the testing and evidence that you need to present so they can review it before the meeting. Then we complete the work based on the FDA feedback’s and then we submit the new data and meet with them again to make sure that we delivered on the clinical trial that we said we’re to deliver on and they were successful. That’s when the whole thing gets concluded, at least this is the path forward. ****SO AFTER reading all of this - one begins to understand the RISK/REWARD scenario. IMO the RISK is rather limited to the REWARD and upside. AGAIN, IMO.
Third, SequestOx. Adjacently the requirements are underway. On July 18, I updated you on the FDAs response, that was only 3 weeks ago. In the past three weeks we ran a multitude of invitro experimentation that stimulated different ole, fatty, acidic, stomach and intestines. We have 3 proposals for the FDA to evaluate that would reduce or eliminate the Tmax delay. We can demonstrate this, we are at DE, but first we need FDA’s feedback and blessing.