Tuesday, March 21, 2017 6:12:24 PM
http://abusedeterrent.org/Resources/Docs/CBI%20ADF%20Opioids%203.17%20final.pdf
https://www.fda.gov/NewsEvents/Newsroom/FactSheets/ucm514939.htm
Elite's RESPONSE to the ABOVE!!!
http://ir.elitepharma.com/profiles/investor/ResLibraryView.asp?ResLibraryID=83145&GoTopage=1&Category=2163&BzID=2258&t=2086&G=939
http://ir.elitepharma.com/profiles/investor/ResLibraryView.asp?ResLibraryID=82907&GoTopage=1&Category=2163&BzID=2258&t=2086&G=939
NOW let's move on to something else that NEEDS to be UNDERSTOOD about the EVER INCREASING VALUE of ELTP!!!
Elite's "RESPONSE" to the ABOVE!!!
NOW let's keep in MIND something VERY IMPORTANT in TERMS of what I've just LAID OUT!!!
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.
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.
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.
Fear Uncertainty and Doubt FUD It Ain't Going To Work Here Anymore. Notice the lack of question mark.
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