HERE is WHAT long term investors need to UNDERSTAND!!!
– ****1) FDA looks forward to the day, not far in the future, when the majority of opioids on the market are known to be abuse deterrent
Quote: https://www.fda.gov/NewsEvents/Newsroom/FactSheets/ucm514939.htm Elite's RESPONSE to the ABOVE!!!
2) 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.
A) Elite Pharmaceuticals, Inc. Initiates Pivotal Bioequivalence Fed Study For Reformulated SequestOx™
"We are pleased to have this bioequivalence study underway for SequestOx™," commented Nasrat Hakim, President and CEO of Elite. "We are expecting results for this study by the middle of May and re-submitting the NDA prior to the end of the year."
B) Elite Pharmaceuticals Reports Positive Topline Results From A Pivotal Bioequivalence Study For A Generic OxyContin®
"Following our recent announcement regarding a successful FDA meeting for our immediate release Oxycodone HCl product SequestOx™, I am now very pleased to announce these positive topline study results for an abuse-deterrent twice-daily Oxycodone," said Nasrat Hakim, President and CEO of Elite Pharmaceuticals. "We intend to file an ANDA for this product later this year."
NOW let's move on to something else that NEEDS to be UNDERSTOOD about the EVER INCREASING VALUE of ELTP!!!
3) FDA’s Woodcock: Generic Drug Application Backlog Will be Eliminated Before GDUFA II - See more at: http://www.raps.org/Regulatory-Focus/News/2016/01/28/24195/FDA%E2%80%99s-Woodcock-Generic-Drug-Application-Backlog-Will-be-Eliminated-Before-GDUFA-II/#sthash.ofKu8nJX.dpuf
Quote: Elite's "RESPONSE" to the ABOVE!!!
Woodcock made clear that the median times cited by Alexander include ANDAs that have technically been backlogged since GDUFA began, though this year, it will take FDA about 15 months to respond to a generic firm on their ANDA. And in October 2016, companies can expect to get a response within 10 months from FDA. Woodcock also noted a case when a generic was approved at nine months, and just last month FDA approved 99 ANDAs. - See more at: http://www.raps.org/Regulatory-Focus/News/2016/01/28/24195/FDA%E2%80%99s-Woodcock-Generic-Drug-Application-Backlog-Will-be-Eliminated-Before-GDUFA-II/#sthash.ofKu8nJX.dpuf
A) Elite Pharmaceuticals Files ANDA To Market Generic Percocet - AUGUST 2016 (7 MONTHS!!)
Percocet and its generic equivalents had total US sales of approximately $700 million in 2015, according to IMS Health data.
"Oxycodone APAP is a strategic addition to Elite's portfolio. It is an immediate release opioid product used extensively by doctors today in pain management. The APAP creates irritation if the product is crushed and taken intranasally, and so may provide some intranasal abuse-deterrence according to the FDA," said Nasrat Hakim, President and CEO of Elite. "Elite is committed to developing a diverse range of opioid abuse-deterrent products both using our proprietary technology and building a foundation of attractive niche generic drugs. Elite also expects to file another generic opioid product this year."
B) Elite Pharmaceuticals Files ANDA For Hydrocodone And Acetaminophen Combo
The combination products of hydrocodone and acetaminophen have total annual US sales of approximately $700 million according to IMS Health data.
"Hydrocodone/acetaminophen is a strategic addition to Elite's pain medicine portfolio. This immediate release opioid product is used extensively by doctors today in pain management. The acetaminophen creates irritation if the product is crushed and taken intranasally, thereby potentially providing some intranasal abuse-deterrence according to the FDA," said Nasrat Hakim, President and CEO of Elite. "Elite is committed to developing a diverse range of opioid abuse-deterrent pain products using our proprietary technology and building a foundation of attractive niche generic drugs."
NOW let's keep in MIND something VERY IMPORTANT in TERMS of what I've just LAID OUT!!!
*****Immediate-release opioids account for 90 percent of the total U.S. opioid market. An estimated 91 percent of all prescription opioid abusers have abused immediate-release opioids. There are currently no FDA abuse-deterrent LABELED, IR opioids on the MARKET!!!
THUS Elite has 2 ADT IR generic opioids ALREADY FILED with the FDA NOW!!!! AND SequestOx will be FILED later this year!!!
NOW let us KEEP in MIND something ELSE NASRAT has conveyed to SHAREHOLDERS!!! 1) HE STATED he plans on FILING 6 ANDAS - ONE each QUARTER for six quarters - He's already filed 2 of the 6!!! THAT means 1 ANDA is due to be FILED ANY DAY NOW!!!! ~~ MY BET A GENERIC EMBEDA!!! 2) Nasrat is WORKING on the SUNGEN 4 ANDAS currently and is scheduled to file these 4 products in about 11 MONTHS!!! 3) *****TAKE NOTE: Pfizer is supposedly launching Troxyca in July of this year: SAVING ELITE BTN 30-70 Million Dollars in R&D funds!!!
The pharmacological approach however can be used and is being used for us to create Oxy products. That would be Pfizer's TROXYCA. Elite expect to develop a generic for TROXYCA as soon as Pfizer launches the product.
We expect the development program to be a lot less costly, of course, if we are making a generic versus making a NDA for the BID, it can run us about $30 million to $70 million. The generic will be a fraction of a fraction of that, and we will take the necessary steps once we hear what the FDA have to say and Pfizer gets their product to the market.
SOME ADDITIONAL info TELLING investors Elite is continuing to GROW by LEAPS and BOUNDS - MEANING INTRINSIC value will GROW adding to the MARKET VALUE $$$$$$$$
1) The expansion of the facility is now complete. We do continue to add equipment to supplement our capacity. We made another key addition to our management team with hiring of Dr. Catherine Hedrick. She is an MD and will oversee our Medical Affairs and Regulatory Affairs Department.
2) Our objective is to be profitable enough to also cover our R&D spending. Our pipeline is moving us to that point. Regarding the warning letter, we have responded to the FDA regarding the pharmacovigilance issues and we have received the deploy and acknowledgement. We used an outside group to formulate the response and recommendations, the outside group also assisted us in implementing the recommendations. Among the changes, we have also hired an MD as I just discussed to enhance the Medical Affairs Department.
3) A question on Dantrolene and Loxapine, what is the status of the site transfer for Dantrolene and Loxapine? I'm disappointed with how slow things are moving, so we are in discussions of moving the products to Elite. The Epic has been caught up with the transition and the whole bunch of other stuff and we are a little more nimble than Epic, so we are going to work with them on transferring these products over here and I will update you about that in next meeting.
Quote: 4) Finally Elite is in the best financial shape in her history, has the best infrastructure ever and most importantly an excellent pipeline that is so charged up that it is becoming a little forgiving. It allow us to tolerate regulatory delays, and less-than-perfect performances, and it is still forgiving enough for us to be able to get the fundamentals necessary to get to dollar land and get into NASDAQ.
*****THE BOTTOM LINE******