Elite Pharmaceuticals Inc (ELTP)

[The ELTP King]

********** MUST READ!!!!! - OCTOBER 8 ADCOM MEETING **********

Folks, October 8 may set the future for Elite.

This is the very first FDA Advisory Committee meeting for an abuse-deterrent stimulant in the HISTORY of mankind.

Here is the link with all the info:

https://www.fda.gov/advisory-committees/advisory-committee-calendar/updated-time-and-meeting-materials-information-october-8-2020-joint-meeting-psychopharmacologic

Remember, I posted about Arbor Pharmaceuticals a few days ago. Their PDUFA date is November 15, 2020, but they must have an Advisory Committee meeting first which is taking place on October 8. Just to remind everyone, the FDA almost ALWAYS follows the vote of the Advisory Committee. Therefore, October 8 is basically make or break.

And remember, I was one who asked Nasrat about abuse-deterrent stimulants in the June 2020 conference call in which Nasrat responded to me and said quote, "That's a very good question".

Time
October 8, 2020 8 a.m. to 5 p.m. EST

Webcast Information
CDER plans to provide a free of charge, live webcast of the October 8, 2020 Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee.

Agenda
The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. The committees will discuss new drug application (NDA) 211179, for amphetamine sulfate immediate-release oral capsules, submitted by Arbor Pharmaceuticals, LLC, for the proposed indication of treatment of attention deficit hyperactivity disorder. The product has been formulated with properties intended to deter non-oral abuse, and the applicant has submitted data to support these abuse-deterrent properties for this product. The committees will be asked to discuss the overall risk-benefit profile of the product, including the potential public health impact, and whether the applicant has demonstrated abuse-deterrent properties for their product that would support labeling.

***** Must Read #1 - ADT Stimulant!!!!! *****

Abuse-Deterrent Amphetamine Shines for Adult ADHD

— AR19 formulated with physical and chemical barriers against misuse

PDUFA target action date: November 15, 2020