There was a coordinated effort across several forums based on the hype of having a novel drug with a big market and hope of either a partnership with Big Pharma or a buyout. It helped that Nasrat had mentioned partnerships. The pump was why I learned about this stock. Alas, that kind of effort doesn't work as well when there are billions of shares and no novel drug to hype.
***** RIGHT after this press release the stock went to .97 *****
***** AND a few weeks/months before this press release he stated the stock is valued at $2.10 *****
Feb 18, 2014
Elite Pharmaceuticals Reports Results Of Pilot Bioequivalence Study For ELI-201
Provides Update on Pivotal Study for Second Opioid Abuse Deterrent Product and Manufacturing Transfer of Generic Products
Northvale, New Jersey, Tuesday, February 18, 2014: Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCBB: ELTP) announced today successful results from a pilot bioequivalence study initiated in December 2013 for ELI-201, a twice-daily opioid abuse deterrent oxycodone product with abuse deterrent technology. Three different twice daily formulations developed by Elite were tested in the study. The study results demonstrate that all formulations in the study were bioequivalent to the reference drug based on pharmacokinetic measures including peak plasma concentration (Cmax) and area under the curve (AUC) for oxycodone blood plasma levels. The study was a single dose, open label, randomized, four period, four treatment, cross over study in 16 healthy volunteers under fasted conditions.
The formulations tested utilize Elite's proprietary pharmacological abuse deterrent technology with the opioid antagonist naltrexone. Levels of sequestration of naltrexone were evaluated based upon a naltrexone assay with a level of detection (LOD) of 4 pc/mL. The study results demonstrated that Elite's formulations were superior to an approved and marketed comparator product using a similar pharmacological approach. The comparison was based upon publicly available data from a similar fasted study in healthy volunteers and using a similar naltrexone assay with an LOD of 4 pc/mL. The primary metabolite of naltrexone, 6-Beta-natrexol, was also analyzed in the Elite study although no data from the comparator product was available for direct comparison.
As previously announced, Elite initiated a pivotal bioequivalence study for an undisclosed opioid abuse deterrent product in January and dosing for this study has now been completed. Results from the study are expected in March.
In addition, supplements are being prepared to file with the FDA for manufacturing site transfers for the first four of twelve approved generic products. Elite expects to file a Changes Being Effected in 30 days (CBE-30) in March for Isradipine, 2.5 mg and 5.0 mg capsules for transfer of manufacturing of this product to Elite's facility. Elite also expects that its partner, Epic Pharma, will file with the FDA a CBE-30 for Dantrolene Sodium, 25 mg, 50 mg and 100 mg capsules, Loxapine 5mg, 10mg, 25 mg, 50 mg capsules and Hydroxyzine 10 mg, 25 mg, 50 mg tablets for transfer of manufacturing of this product to Epic's facility in June. Although we hope to launch the products 30 days after these filings, Elite cannot guarantee when these products will launch as it is dependent on FDA acceptance of the filing.
"We are delighted with the results from our clinical studies and pleased to have confirmation of the formulation for our extended release product, ELI-201, our twice-daily oxycodone product and the progress of the second opioid," stated Nasrat Hakim, President and CEO for Elite. "We are also on track with the manufacturing site transfer of the twelve generic products Elite is adding to the product line. The transfers of these products have been prioritized and we will have additional supplements to file following these first two products."
BTW, I'm ready for it. 15:1 reverse split, leaving ~75M outstanding and ~100M authorized. Stop pretending it might not happen and get it over with already.