Saturday, December 28, 2019

Elite Comes Through

2020 is here and it looks like $ELTP made critical changes that may lead to some big days ahead.  Big green days.  GMAN24 nailed it by posting these two comments to support the buzz.

Some thoughts from N2k

A final thought: Based on a strategic decision that totally realigned its product focus (and which cost additional shares to fund), Elite has become a well-diversified generics company. As a generics firm, the focus is on price not differentiation. SOX was an NDA and, thus, differentiated. It was a strategic anomaly and, I believe, a mistaken decision for a generics firm to make. But I forgive them the mistake because they are not attempting to escalate their financial commitment to an opioid product line that has socio-legal-political issues. Moreover, ADFs, while a grand idea, are and remain a costly drug. ICER has put out a report that indicates ADF opioids are overpriced by 40% and it is a major reason they will not gain the traction with the now cautious prescribers who do not believe their patients are at risk of abuse or diversion. Because the cost of ADF opioids is high, abuse threat low, and many of these people are on fixed incomes and sensitive to pricing, healthcare professionals will not easily prescribe ADFs.

And, there is the fact that the CNS ANDAs will be more profitable and reach a larger market.

So it is that we investors owe Nasrat and Elite a vote of thanks, respect and trust. Management is moving Elite toward success that early investors could not have imagined and it is because at a key tipping point they made a strategic decision that now finds the company with increasing revenues and on the doorstep of financial success. I am now invested in a better company than when I first began.


WeeZuhl
Yesterday was the biggest day in the history of Elite Pharmaceuticals. We have never had any product with this much upside potential. It is particularly beneficial that the company has API quota in place and is ready to ship product within a few weeks to a distributor with the name and infrastructure to immediately start gaining market share. I say this is the "next phase" for two reasons: the IR and ER Adderall products will (1) make this company profitable (E is for earnings) and (2) allow further development without further dilution.


Congratulations to all long term investors. This is what we've been waiting for. Lots of investors have found this stock along the away, but I offer special praise to those investors with the insight and patience necessary to recognize the ongoing potential despite the recurrent setbacks. And while I am praising insight and patience, let's not forget Elite management. While the future of ADF opioids is in doubt, the future of Elite Pharmaceutical is very clear. For that fact alone, I give Nasrat Hakim great credit. I believe he showed true vision and was ahead of his peers in seeing problems in the ADF market and general decline in opioid prescriptions. The timely transition to ADHD drugs was a smart choice that aligns perfectly with Elite's model of niche drugs with high barriers to entry. The team has the facilities well-prepared, and the right products are starting to line up.


The next phase will require a second shift. It's time for our factory to get busy. We've literally got a license to cook crank, so let's really start slinging that speed!

Thursday, December 26, 2019

Elite Pharmaceuticals 2020 Looks Up

Trudging slowly over the pharmaceutical stock pile is not laughing matter.   So much hangs on their pipelines which dangle like a carrot as the FDA makes their methodical decisions that either propel or body slam a stock to its new dimension.

Elite has made some amazing achievements in a timely manner in 2019. 

Dec 12, 2019
Elite Pharmaceuticals, Inc.: Elite Pharmaceuticals and SunGen Pharma Receive FDA Approval for Generic Adderall XR(R)
NORTHVALE, NJ / ACCESSWIRE / December 12, 2019 / Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCQB:ELTP), a specialty pharmaceutical company developing its own generic products, partnered generic products and proprietary abuse-deterrent opioids, today announced that it received approval from the US Food and Drug Administration (FDA) for a generic version of Adderall XR®, an extended-release mixed salt of a single entity Amphetamine product (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate) with strengths of 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg capsules. The product is a central nervous system stimulant and is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). According to IQVIA (formerly QuintilesIMS Health) data, the branded product and its equivalents had total U.S. sales of $1.3 billion for the twelve months ending October 2019.
Generic Adderall XR is jointly owned and the second product approval for our Elite and SunGen Pharma LLC ("SunGen") collaboration. Elite will manufacture and package the product on a cost-plus basis. Lannett Company, Inc. will be the exclusive U.S. distributor.
"We are pleased to have received approval of this second product co-developed with our partner, SunGen," said Nasrat Hakim, President and CEO of Elite. "Launch of this product is our top priority."
"We are very pleased to have another ANDA approval through our partnership with Elite and achieve a significant milestone for Sungen as we work on the launch of the recently approved generic Adderall XR®," said Dr. Jim Huang, Co-CEO of SunGen.