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Are you implying that the FDA doesn't give PDUFA extensions if they have already granted a company Priority Review status for a particular product?
Thanks
Much appreciated. Thank you.
I stand corrected. Thanks Lasers.
Hondo,
I agree with your post. My concern is that the calendar posted on the FDA Advisory Committee webpage may not be all that up to date. I've attached a link to an August 5th Advisory Committee meeting for Remoxy...
http://sonoranweeklyreview.com/pain-therapeutics-says-fda-advisory-committee-to-review-pain-drug-remoxy-on-august-5-nasdaqptie/
Which has yet to be posted on the FDA site...
http://www.fda.gov/AdvisoryCommittees/Calendar/
http://onlinelibrary.wiley.com/store/10.1038/sj.bjp.0705378/asset/sj.bjp.0705378.pdf?v=1&t=ioo691x8&s=b79d234af0c00fd201d55bf844bd76b4aedde5ee
Systemic administration of fentanyl increased extracellular 5-HT in the DRN, and this effect was blocked by the opioid receptor antagonist naltrexone. In contrast, fentanyl infusion into the DRN decreased 5-HT. Neither naltrexone, which is a m- preferring antagonist, nor a k-opioid receptor antagonist nor- BNI prevented this effect.
I don't know when this Corporate Presentation dated April 15, 2016 was added to the company website, but it's a great summary for anyone interested in obtaining a concise synopsis of everything ELTP.
http://ir.elitepharma.com/Profiles/Investor/Investor.asp?BzID=2258&from=du&ID=66904&myID=16024&L=I&Validate=4
FDA Denies Without Comment Purdue Petition re PFE ALO-02 (Oxycodone)
https://www.regulations.gov/#!documentDetail;D=FDA-2015-P-5108-0012
I believe that means the authors were asked to be present by their poster (for poster 442 it was yesterday from 15:34-17:15) to answer questions from meeting attendees.
I don't think that there is an actual oral presentation, although a poster presentation is indeed a presentation.
The PR from Elite stated that the SequestOx data was going to be presented, and it was.
Prettig weekend Thorfin.
That's my understanding.
Good morning Lasers, thanks for the question.
For what it's worth, this is what I know (see link below):
All the posters were to be displayed May 11th-13th. There were two Author-Attended Sessions yesterday (again see link for details).
People attending the Annual Meeting were posting photos on Twitter @APS2016 and @AmericanPainSoc, unfortunately I didn't see any of poster #442.
I'm unaware of any other presentation given by Dr. Setnik regarding the $ELTP abstract.
http://americanpainsociety.org/annual-meeting/2016/poster-abstracts
I hope this helped.
This upcoming Webinar featuring Dr. Beatrice Setnik should be very informative:
https://scontent-lga3-1.xx.fbcdn.net/v/t1.0-9/13125023_10154195176428628_5480087792964462222_n.jpg?oh=997f8bd0d55c1bd456cd20e284b51280&oe=57AB7AAE
http://www.drugscan.com/images/stories/drugscan/pressrelease/DrugscanWebinarpressrelease.pdf
In response to wether the posters submitted are peer reviewed, here is the response from the American Pain Society:
Dear ________
Thank you for contacting the American Pain Society (APS). In response to your inquiry, please find the most recent accepted abstracts here: http://americanpainsociety.org/annual-meeting/2016/poster-abstracts. All posters (accepted and rejected) go through a peer review process and each author is required to file a disclosure conflict of interest form.
Please let me know if you have futher questions or concerns.
Thank you,
Heather Payette
Member Services
American Pain Society
Translating research into relief.
8735 W. Higgins Road, Suite 300 * Chicago, IL 60631
(847) 375-4715 * fax (847) 375-6479 * hpayette@Connect2amc.com
http://www.ampainsoc.org/
For those you are interested about the outcome of the FDA Advisory Committee meeting today with KemPharm
https://globenewswire.com/news-release/2016/05/05/837181/0/en/Statement-Regarding-FDA-Advisory-Committee-Meeting-on-KemPharm-s-Abuse-Deterrent-Product-Candidate-Apadaz.html
Are you sure you know exactly what he is saying?
Elite Pharmaceuticals' (ELTP) CEO Nasrat Hakim on Q3 2016 Results - Earnings Call Transcript
"We do have capacity in the current manufacturing facility in order to make the product and for product launch. The facility today in its present form is sufficient to handle product launch for SequestOx. We will not manufacture launch quantities till we get closer to the launch date. Again we are a small company. I don’t want any surprises, I don’t want a question from the FDA, I don’t want any delays, and therefore we’re not going to take any chances and we’re going to wait. And to give you an example on here, Pfizer filed their Oxy BID and they got priority review and the FDA at the end of the prior review said we would need three more months to discuss it further and after the three months, they also needed some more time because has not disclosed. If we make launch quantities, it will be sure dated and will be about to expire, and we’re not going to take that risk. We will wait till all the events are lined up in our favor and then we will go ahead and make the launch quantities. The launch quantity should not take that long. Therefore it’s not really a showstopper, or not even a bottleneck."
Elite Pharmaceuticals Appoints Davis S. Caskey to Its Board of Directors
NORTHVALE, N.J., May 04, 2016 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCBB:ELTP) announced today that its Board of Directors has appointed Davis S. Caskey to its board effective April 28, 2016.
Davis Caskey is the newest member of Elite's Board and brings more than 40 years of pharmaceutical industry experience to this position. From 1990 until 2013, Mr. Caskey was employed by ECR Pharmaceuticals Co., Inc. ("ECR"), a venture that was founded in 1990 and acquired by Hi-Tech Pharmacal in March 2009, where he served as the operating officer. Upon leaving ECR, Mr. Caskey formed Caskey LLC, an umbrella company to provide consulting services to the pharmaceutical industry and for the management of other business interests. While at ECR, Mr. Caskey was credited with the establishment of ECR's sales and marketing structure, its product distribution format, and management of the firm's internal organization. His responsibilities included the oversight of drug development and regulatory filings. A primary focus was to conceive and develop, with the assistance of key strategic partners, extended release formulations of products which enhance patient compliance and safety. Prior to ECR, Mr. Caskey was employed by A.H. Robins for 18 years. His experience brings critical insight into the marketing and distribution of pharmaceutical products in a rapid and ever changing competitive marketplace. Mr. Caskey attended the University of Texas (Austin) and Lamar University, and holds bachelor's and master's degrees.
"We are delighted to welcome Davis Caskey to our Board of Directors where his pharmaceutical industry expertise will have an invaluable impact on the success of Elite," stated Nasrat Hakim, Elite's Chairman of the Board. "We look forward to his guidance and expertise as we expand our pharmaceutical operations."
Abuse-Deterrent Opioid Bill Breezes Through House Committee
http://www.fdanews.com/articles/176451-abuse-deterrent-opioid-bill-breezes-through-house-committee?utm_source=hs_email&utm_medium=email&utm_content=29231292&_hsenc=p2ANqtz-9ieVa7n9Kx8K4H-rE0f8bH-VGmR99zWNa8bRKQqftlMCpMM0SZjiv5P3megbeyjRInzt-RZfkKhuBl5gK03fJewFfEMg&_hsmi=29231292
Your spelling of the work quiet is quite impressive.
Markey Looks for Answers on FDA’s Opioid Approval Process
http://www.fdanews.com/articles/176376-markey-looks-for-answers-on-fdas-opioid-approval-process?utm_source=hs_email&utm_medium=email&utm_content=29007791&_hsenc=p2ANqtz-95BKSpCzfbqr4ZGfN6UZVqCMqq6LGvsJWzH6kiJImDi7bvT1GS7rgwrx7icy8Nu3h63PB8P4XOIvov_Pnlzq28kmxu1w&_hsmi=29007791
Abuse-Deterrent Opioid Bill Skates Through E&C Subcommittee
http://www.fdanews.com/articles/176362-abuse-deterrent-opioid-bill-skates-through-ec-subcommittee?utm_source=hs_email&utm_medium=email&utm_content=28946516&_hsenc=p2ANqtz-_D1ETkrPQXOGgvUXYpTri8-OySatbQRIr_f0fkAQ-6ug-wMcUpb5XcGpIz4q2AHBJF-ozJe7krNmXyZVP-jJBVmymWpQ&_hsmi=28946516
A third job posting has been added to the website...
http://www.elitepharma.com/careers/
South Plainfield, NJ – March 30, 2016 – Humanwell Healthcare Group and PuraCap Pharmaceutical LLC announced today that the companies have entered into a definitive agreement to acquire 100% of the membership interests of Epic Pharma, LLC of Laurelton, NY for $550 million. The acquisition will further establish Humanwell and PuraCap in the US generics market and expand their existing commercial and manufacturing capabilities.
The acquisition of Epic will provide a robust generic product portfolio which includes tablets, 2-piece capsules and powder dosage form products as well as a future product portfolio that will include a series of controlled drug substances.....that last part sounds suspiciously like Elite.
Humanwell, PuraCap Acquire Epic Pharma for $550M
Humanwell Healthcare Group and PuraCap Pharmaceutical said today they agreed to acquire Epic Pharma for $550 million.
The buyers said the deal will expand both their commercial and manufacturing capabilities, as well as their presence in the U.S. generics market.
Epic's portfolio consists of 15 marketed generic products consisting of tablets, two-piece capsules, and powder dosage form products, as well as a pipeline of 37 products that includes controlled drug substances.
Humanwell and PuraCap said the deal was designed in part to complement PuraCap's existing R&D efforts by using Epic's know-how in manufacturing and developing controlled drug substances and powder formulations.
As part of the deal, the buyers will acquire Epic’s FDA and U.S. Drug Enforcement Agency–inspected Good Manufacturing Practice (GMP) manufacturing site, a 110,000-square-foot facility in Laurelton, NY. That will add 215 employees to the Humanwell and PuraCap U.S. operations team, the companies said.
“The addition of Epic is an important addition to the PuraCap family,” Dahai Guo, CEO of PuraCap and president of Humanwell USA, said in a statement. “We look forward to it being a platform for the development of our generic pharmaceutical business, both in the USA as well as internationally."
The companies said the deal is expected to close in the scond quarter subject to customary conditions that include expiration of the waiting period under the Hart–Scott–Rodino Antitrust Improvements Act, approval of Humanwell stockholders, and registrations from certain governmental entities in China.
Chinese-based Humanwell specializes in investing, developing, and managing healthcare companies. Founded in 1993, the publicly traded company has a market capitalization of $3.5 billion.
PuraCap oversees two companies: PuraCap Pharmaceutical, focused on prescription brand-name drugs, and PuraCap International, which markets prescription generics and over-the-counter (OTC) and private-label brands.
PuraCap International, a joint venture with Dangdai International Group, was created just last week when PuraCap Pharmaceutical acquired two other companies, Blu Pharmaceutical and Blu Caribe, in a deal announced March 24.
That deal expanded PuraCap's manufacturing expertise beyond soft gelatin capsules to include oral tablet and capsule dosage forms for both the U.S. and global markets. Under the transaction, PuraCap acquired a 145,000 square-foot current GMP (CGMP) manufacturing facility in Dorado, Puerto Rico, and a 185,000 square-foot warehouse and distribution center in Franklin, KY.
Endeavor Clinial Trials Not yet recruiting???
San Antonio, Texas, United States, 78240
Contact: Kathy Diaz
Principal Investigator: Richard Pollak, DPM
According to the link they are indeed recruiting...
http://www.endeavorct.com/bunion-removal-0
Would adding that information onto the sticky notes for all to read be of any use?
Can you provide me with that link? Thanks
Great synopsis. Thanks
News
Elite Pharmaceuticals Announces Conversion of Treppel Bridge Loan to Convertible Note
Elite Pharmaceuticals, Inc. ("Elite") (OTCBB:ELTP) announced today that Jerry Treppel, Elite's Chairman of the Board, has elected to convert the outstanding principal amount owed as part of the $1 million Treppel Credit Line to an unsecured convertible note ("Note"). The Treppel Credit Line remains in effect and is available, in full, through July 2014, the remaining term of the credit line.
Pursuant to the terms of the Treppel Credit Line, all unpaid principal amounts carried an interest rate of 10%, and required payment in full on or before July 31, 2014. The current principal amount of $600,000 due under the Treppel Credit Line has now been converted to an interest free, convertible note, which matures in November 2016. The convertible note can be paid via the issuance of common stock in lieu of cash, at the option of Mr. Treppel and in accordance with the Note.
Mr. Treppel stated that "Elite is now in the best financial, operational, and product development position in its history. Elite is only days away from the beginning of its first human clinical trial on its twice daily oxycodone/naltrexone product. I welcome the opportunity to substantially increase my equity position in the company."
Additional details regarding the convertible note will be included in a Current Report on Form 8-K which will be filed with the Securities and Exchange Commission.
I looked up the PRs from Alexza Pharma and it looks like this dates back to 2007
Nasrat Hakim Joins Alexza Pharmaceuticals as Vice President, Quality
Date : 07/18/2007 @ 5:52PM
Source : PR Newswire (US)
Stock : Alexza Pharmaceuticals, Inc. (MM) (ALXA)
Quote : 5.13 -0.15 (-2.84%) @ 8:10PM
You were right, I emailed Dianne. It was a typo. Thanks
Notice the date in Item 3.02 Unregistered Sales of Equity
September 10, 2012....one year ago.
Current Report Filing (8-k)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
Current Report
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
September 10, 2013
--------------------------------------------
Date of Report (Date of earliest event reported)
ELITE PHARMACEUTICALS INC.
--------------------------------------------------------
(Exact name of registrant as specified in its charter)
Nevada 001-15697 22-3542636
(State or other jurisdiction (Commission (IRS Employer
of incorporation) File Number) Identification No.)
165 Ludlow Avenue, Northvale NJ 07647
------------------------------------------------------------------
(Address of principal executive offices)
(201) 750-2646
---------------------------
(Registrant’s telephone number, including area code)
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 3.02. Unregistered Sales of Equity
On September 10, 2012, Epic Investments exercised the remaining Series E Convertible Preferred Stock. Pursuant to the terms of the Series E Convertible Preferred Stock, 65,843,621 shares of common stock were issued to Epic Investments upon the conversion.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Dated: September 13, 2013
ELITE PHARMACEUTICALS, INC.
By: /s/ Nasrat Hakim
Nasrat Hakim
President and Chief Executive Officer
A picture worth a thousand words...
Doubt it
Can someone provide a link for new website, can't seem to find it.
Thank you.