A lot of folks on the message boards said this wouldn't happen for years, if ever. Now most certainly they are doubting that it will be accepted. What a day for Elite!!!
Saturday, January 30, 2016
Wednesday, January 13, 2016
How is FDA waving Elite's filing fee anything but a good thing?
FDA Approves Waiver of NDA Filing Fee for Elite Pharmaceuticals
Elite to Submit New Drug Application for ELI-200
NORTHVALE, N.J.,
Jan. 13, 2016 (GLOBE NEWSWIRE) -- The United State Food and Drug
Administration (“FDA”) granted Elite Pharmaceuticals, Inc. ("Elite" or
the “Company") (ELTP)
a waiver of the application fee required for the filing of a New Drug
Application (NDA). Under section 736(d)(1)(E) of the Federal Food, Drug
and Cosmetic Act the FDA may grant a waiver of the $2,335,200 NDA
application fee for the first human drug application that a small
business submits for review.
Elite
will immediately submit a 505(b)(2) New Drug Application for its lead
opioid abuse-deterrent candidate ELI-200, immediate-release Oxycodone
Hydrochloride 5mg, 10mg, 15 mg, 20 mg and 30mg capsules with sequestered
Naltrexone Hydrochloride, for the treatment of moderate to severe pain
with the United States Food and Drug Administration. FDA notification
regarding acceptance of the submission for review is expected to take 6
to 12 weeks.
"Having the
FDA waive the application fee is a huge benefit to Elite. We will file
the ELI-200 submission immediately. I look forward to hearing from the
FDA concerning a notification of the acceptance for review in the coming
weeks,” said Nasrat Hakim, President and Chief Executive Officer of
Elite.
Hakim Named ELTP's Chairman of the Board
NORTHVALE, N.J., Jan. 13, 2016 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the “Company") (ELTP)
announced that Jerry Treppel has resigned as the Company’s Chairman and
as a member of the Board of Directors, effective January 11, 2016, to
pursue other opportunities.
The Board of Directors has appointed Nasrat Hakim, Elite’s President and CEO to serve as Chairman of the Board of Directors.
“I
want to thank Jerry for his years of dedicated service and
contributions to the company, and I wish him all the best in his future
endeavors,” said Mr. Hakim.
Mr.
Treppel stated, “I am proud of the accomplishments of the company
during my time on the Board. It has been my pleasure to work with
Elite’s team and I am confident that the company is well-positioned for
the future as it continues to execute on its strategy.”
So what is the point? Anyone out there in comment-land have any idea why this happened? Was this to open up a seat on the board for someone new? Who could it be??
So what is the point? Anyone out there in comment-land have any idea why this happened? Was this to open up a seat on the board for someone new? Who could it be??
Sunday, January 10, 2016
This $ELTP blog has been right and wrong
Since I began following Elite Pharmaceuticals 6 years ago I can say that there has been a lot to cheer and jeer concerning how far management has actually come. We have seen Jerry step aside at the best possible time and the entrance of Hakim (aka Mikah). Overall he has kept ELTP a contender in the ADT drive for market-share. Shareholders are happy about many milestones, a hefty product pipeline, non-fluff PR, a conservative approach to an incredibly difficult sector of the market and individual product successes. Of course that wouldn't come without speculation, broken time-windows, a long played-out FDA process, and of course years of awaiting the arrival of their star AFT formula.
In the meanwhile, in between PR and approvals, we have chat threads to gather DD from folks on chat boards with a deeper understanding of the medication development processes and other speculation on both sides of the fence. The pumpers and the dumpers are polar opposite in their views, while most of Elite's most knowledgeable and objective posters have removed themselves from the conversation for good measure.
More than ever the speculation is doom or glory, IMO, if there's a REJECTION stamp from the FDA for Elite's ELI-200 formula, are we looking at a collapse? With all Elite has going for them, including a recent successful Phase-3 study under the belt (The pivotal trial met its primary endpoint (p = 0.001), demonstrating statistical significance that the product provided pain relief following surgery in the treatment group using ELI-200 compared to the placebo group. Secondary endpoint results were consistent with primary findings and included safety measures. There were no serious adverse events or deaths related to ELI-200 reported during the conduct of the trial.), you would like to think the safeguards are in place. I won't speculate much further than this, but last week's poor performance can be be blamed on various factors including China, submission waiting (for their ADT) to FDA, or a lack of share volume.
In the meanwhile, in between PR and approvals, we have chat threads to gather DD from folks on chat boards with a deeper understanding of the medication development processes and other speculation on both sides of the fence. The pumpers and the dumpers are polar opposite in their views, while most of Elite's most knowledgeable and objective posters have removed themselves from the conversation for good measure.
More than ever the speculation is doom or glory, IMO, if there's a REJECTION stamp from the FDA for Elite's ELI-200 formula, are we looking at a collapse? With all Elite has going for them, including a recent successful Phase-3 study under the belt (The pivotal trial met its primary endpoint (p = 0.001), demonstrating statistical significance that the product provided pain relief following surgery in the treatment group using ELI-200 compared to the placebo group. Secondary endpoint results were consistent with primary findings and included safety measures. There were no serious adverse events or deaths related to ELI-200 reported during the conduct of the trial.), you would like to think the safeguards are in place. I won't speculate much further than this, but last week's poor performance can be be blamed on various factors including China, submission waiting (for their ADT) to FDA, or a lack of share volume.
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