Elite Pharmaceuticals Inc (ELTP)

[NASDAQ2020]

No one has ever been harmed by original or reformulated SequestOx.
Nasrat and FDA have found Three fixs for the fed Tmax.
Two in the bank for emergency.

SEQUESTOX GREEN LIGHTED BY FDA IN DEC
Elite brought THREE oxy formulations to the Dec FDA meeting and placed them on the table, they were all within the accepted fed Tmax range.
FDA liked the Invitro and InVivo data presented for ALL three.
FDA granted Three Clear pathways for SequestOx.

InVivo testing started 2017.

Quote:


"Elite Pharma provides Update on SequestOx™ New Drug Application
GLOBENEWSWIRE 12:32 PM ET 12/22/2016

ELTP (+8.65%)

NORTHVALE, N.J., Dec. 22, 2016 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc.(ELTP) ("Elite" or the “Company") today announced the Company met with the U.S. Food and Drug Administration (the “FDA”) on December 21, 2016 for an end-of-review meeting to discuss steps that Elite can take to obtain approval of SequestOx™. Based on the FDA response, the Company believes there is a "clear" path forward to address the issues cited in the July 14th Complete Response Letter (“CRL”). The FDA will provide minutes of the meeting by the end of January and the Company will issue a further update at that time."




Elite Reports On SequestOx™ FDA End-of-Review Meeting

Elite Will Proceed with Studies Required for an NDA Resubmission

Quote:

NORTHVALE, N.J., Jan. 23, 2017 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCBB:ELTP) today reported the Company received official minutes from its December 21, 2016 end-of-review meeting with the U.S. Food and Drug Administration (the "FDA") for the New Drug Application (the "NDA") for SequestOx™ (oxycodone hydrochloride and sequestered naltrexone hydrochloride). The meeting minutes support a plan to address the issues cited by the FDA in the July 14th Complete Response Letter by modifying the SequestOxTM formulation. Elite will proceed immediately to complete in vitro and in vivo bridging studies required and expects to resubmit the SequestOxTM application later this year. The in vivo studies include bioequivalence and bioavailability fed and fasted studies comparing the modified formulation to the original formulation.


SequestOx™ is Elite's investigational abuse-deterrent opioid candidate for the management of moderate to severe acute pain where the use of an opioid analgesic is appropriate.

"We are very pleased that the meeting discussions with the FDA provide a clear path forward for SequestOx™," said Nasrat Hakim, President and CEO of Elite. "Based on the guidance received from the agency, we plan to initiate the bridging studies immediately and are expecting to resubmit our NDA this year."

FOR GREATER DETAILS OF THE DEC FDA MEETING LISTEN TO THE LAST CC.

Quote:

Regarding our pipeline, I will start with SequestOx. We are pleased with the past meeting with the FDA on SequestOx. We issued a press release, the day after the meeting summarizing the discussions and as promised, we followed up with another press release when the final meeting minutes were issued.

The stock did not respond to the second press release for reasons that are now really clear to me, so let me go through - go over our meeting and our past forward for SequestOx. Elite developed and proposed a three simple formulation modifications supported by lab studies, in vitro studies. Anyone of the three we believe will address at the AHT [indiscernible].

The FDA agreed that any of the three proposed modifications would be a minor change. This makes our path to resubmission clear and straightforward. The pass is as follows; we have to chose one of the three formulations and proceed with it and we have done so, complete a Fed BE study to demonstrate that the modification achieved its objective, this is key and this study will be initiated this quarter. If the Fed study is successful, we will then complete the combined fasted BE and dose proportionality.

The other work required include a category one in vitro lab work and stability study. We view this outcome as very positive because it requires only a BE study and not an efficacy study, the cost and time to complete the required BE BA studies is much less than efficacy and follow-up less expensive. We are expecting we can complete the two PK studies and resubmit by year's end.


Quote:

Quote:
Elites ARTechnology is solid. FDA could not find any issues with it.
Extended Release opiods will be a breeze due to no outrageous Tmax requirements with ER opiods.
Quote:
Third, SequestOx. Adjacently the requirements are underway. On July 18, I updated you on the FDAs response, that was only 3 weeks ago. In the past three weeks we ran a multitude of invitro experimentation that stimulated different oily, fatty, acidic, stomach and intestines. We have 3 proposals for the FDA to evaluate that would reduce or eliminate the Tmax delay. We can demonstrate this, WE ARE B.E." !!!!