Wednesday, November 30, 2016 3:04:07 PM
****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?
AWSAccessKeyId=1Y51NDPSZK99KT3F8VG2&Expires=1472651949&Signature=W9GdXe0A2wmlLSkp6Nr6M%2BiMahk%3D
http://www.edgarexplorer.com/EFX_dll/EdgarPro.dll?FetchFilingHTML1?SessionID=JXpSe3-0bA5lo-9&ID=11534435
http://www.edgarexplorer.com/EFX_dll/EdgarPro.dll?FetchFilingHTML1?SessionID=JXpSe3-0bA5lo-9&ID=11497617
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.
http://www.fda.gov/NewsEvents/Newsroom/FactSheets/ucm514939.htm
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
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/
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
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.
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM437431.pdf
http://seekingalpha.com/article/3999933-elite-pharmaceuticals-eltp-ceo-nasrat-hakim-q1-2017-results-earnings-call-transcript?part=single
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.
Fear Uncertainty and Doubt FUD It Ain't Going To Work Here Anymore. Notice the lack of question mark.
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