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Not seeing Elite on that list anymore.
Do they follow a release schedule when updating the website?
What is the status of the warning letter? Feels like it been over a year.
I'm baffled they haven't at least allowed Elite an Advisory Committee review of SequestOX
So what's with the ER pipeline? Are they displaying inconsistencies with the reference drug as well?
How long until the warning is lifted? Feels like that's been going on for a year.
Were there any updates on the ANDA approvals?
Hopefully he's looking at strategic options to build upon all that hard work in the next 6-12 months. It's going to take a better organization to push this over the finish line.
I sure as hell hope the ER ADT is shovel ready for submission.
Do we have an oxymorphone hydrochloride product in development?
Any chance we can pull the time between submittal and approval?
When is the next conference call? I think that would be the most appropriate time to discuss the tMax results. I suspect he's waiting for a formal write up of the results before PR'ing anything. That's not to stop him from mentioning it in a conf call.
Also, LPCIII, with the timing of that arrangement can anyone read into where or if that has anything to do with preliminary tMax results?
What was the final print?
Your only as faithful as your options. Absent alternative funding Elite would be at the mercy of someone else's terms.
Could it be possible this move drives up the price of an acquisition or partnership terms? Essentially removing the excuse they'd have to low ball. Now we have working capital options vs before.
Any idea when we'll start to see those ANDA approvals start to stream in?
Copy, thanks for the clarification
They may have done us a favor by not challenging prior to the CRL. If we needed to wait 30 months only to get a CRL it might have cost us another year and a half.
If so, the 30 months for Sequester OX would expire on or around launch time if Purdue decided to challenge.
Do those 30 months kick in from the time they filed with the FDA or today?
I prefer the quote from Moneyball: "He's got an ugly girlfriend, ugly girlfriend means no confidence"
Coverage of the opioid epidemic is front and center on CNN. I found the article called "Senator opens investigation into opioid manufacturers" particularly interesting. If abuse-deterrent technology is considered a form of risk mitigation it could set Elite up for a buyout with a large premium attached.
Wait until this Kentucky politicians hear that Puracap will be involved in the first IR ADF product on the market. That'll score brownie points in state that has an opioid epidemic.
I can't wait for the steady stream of ANDA approvals to come through. They should start coming through this summer which will be a nice setup for potential good news on SequestOX
Did they run in house studies for all three options and pick the best? Not too familiar with in house studies.
Or to throw a wrench in the MM's playbook.
Anyone else interested to see how the "raw materials" component of the report differs from last Q?
+1Maz, completely agree.
And there's another CTO expiring mid-December as well.
Sounds like buttoning things up for a transaction. Otherwise I'm not sure anyone would care.
Don't forget the ANDA yet to be announced for this quarter.
Does Puracap have anything like that?
ELTP is sure getting cozy with the Chinese. I briefly looked into the Athenex/Sungen relationship and they are into the oncology space. With cancer rates climbing in China it would only make sense to have a complementing pain management portfolio.
They're sitting on something. I know they stayed the API's for Sequest OX would not be procured until they had a solid path to approval. That's a massive variation in raw materials.
Look at the buildup in raw materials.
Release #:2258-163180-rl-1161623:
Elite Pharmaceuticals, Inc. to Host Conference Call to Discuss 2nd Quarter 2017 Financial Results on November 10, 2016
Financials for 2nd Quarter Ended September 30, 2016 will be released on November 9, 2016
NORTHVALE, N.J., Nov. 07, 2016 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCQB:ELTP), a specialty pharmaceutical company developing a pipeline of abuse-deterrent opioids and niche generic products, announced today that its second quarter financial results will be released on Wednesday, November 9, 2016. Elite's management will host a live conference call on Thursday, November 10th at 1:30 PM EST to discuss the company's financial and operating results and provide a general business update. Stockholder questions should be summited to the company in advance of the call.
Conference Call Information
Date: Thursday, November 10, 2016
Time: 1:30 PM EST
Dial-in numbers: 1-800-346-7359 (domestic)
1-973-528-0008 (international)
Conference number: 98840
Questions: dianne@elitepharma.com by 6:00 PM EST on
Wednesday, November 9, 2016
Audio Replay: http://ir.elitepharma.com/events_presentations
About Elite Pharmaceuticals, Inc.
Elite Pharmaceuticals, Inc. is a specialty pharmaceutical company which is developing a pipeline of proprietary pharmacological abuse-deterrent opioid products as well as niche generic products. Elite specializes in oral sustained and controlled release drug products which have high barriers to entry. Elite owns generic and OTC products which have been licensed to TAGI Pharma, Epic Pharma and Valeant Pharmaceuticals International. Elite currently has eight commercial products being sold, additional approved products pending manufacturing site transfer and the NDA for SequestOxâ„¢, for which it just received the CRL from the FDA. Elite's lead pipeline products include abuse-deterrent opioids which utilize the Company's patented proprietary technology and a once-daily opioid. These products include sustained release oral formulations of opioids for the treatment of chronic pain. These formulations are intended to address two major limitations of existing oral opioids: the provision of consistent relief of baseline pain levels and deterrence of potential opioid abuse. Elite also provides contract manufacturing for Ascend Laboratories (a subsidiary of Alkem Laboratories Ltd.). Elite operates a GMP and DEA registered facility for research, development, and manufacturing located in Northvale, NJ. Learn more at www.elitepharma.com.
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Including those related to the effects, if any, on future results, performance or other expectations that may have some correlation to the subject matter of this press release, readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, Elite's ability to obtain FDA approval of the transfers of the ANDAs or the timing of such approval process, delays, uncertainties, inability to obtain necessary ingredients and other factors not under the control of Elite, which may cause actual results, performance or achievements of Elite to be materially different from the results, performance or other expectations that may be implied by these forward-looking statements. These forward-looking statements may include statements regarding the expected timing of approval, if at all, of SequestOxâ„¢ by the FDA, the steps Elite may take as a result of the CRL, the results of an End of Review Meeting and what actions the FDA may require of Elite in order to obtain approval of the NDA. These forward-looking statements are not guarantees of future action or performance. These risks and other factors, including, without limitation, Elite's ability to obtain sufficient funding under the LPC Agreement or from other sources, the timing or results of pending and future clinical trials, regulatory reviews and approvals by the Food and Drug Administration and other regulatory authorities, intellectual property protections and defenses, and the Elite's ability to operate as a going concern, are discussed in Elite's filings with the Securities and Exchange Commission, including its reports on forms 10-K, 10-Q and 8-K. Elite is under no obligation to update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.
Contact:
For Elite Pharmaceuticals,
Inc.
Dianne Will,
Investor Relations,
518-398-6222
Dianne@elitepharma.com
www.elitepharma.com
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Monday, November 07, 2016 12:55:34 PM 1161623
So you say a zero percent chance of buyout?
I only ask since the low volume suggests a reduction in MM activity.
Question for you, in a scenario where a company is on the verge of a buyout would market makers be instructed to stop trades between themselves?
Public Meeting on Pre-Market Evaluation of Abuse-Deterrent Properties of Opioid Drug Products
Does anyone have some extra time to follow these webcasts? It starts today:
http://www.fda.gov/Drugs/NewsEvents/ucm509853.htm
Monday right?