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I'd laugh all the way to the bank... They don't care that im down on this
I agree.. I'm betting on a sharp reversal later today. This is to unreal to go all day like this.
Please keep me updated on progress bud.
Found this presentation saying 18 months for a new drug in 2013...
I'd assume generics are shorter... But its been 4 years since it too so who knows
http://www.mpssociety.ca/Vimizim%20Updates/BM%20MPS%20Society%20Canada%20Drug%20Approval%20Processes%20-%20September,%202013.pdf
Welcome back bud. Might be my time to buy dinner.
Bout time. Let's get this sh*t wagon moving.
I think you've said it once before, sell and move on Doug :P
But they would be acquiring it anyways it doesn't make sense period. And it doesn't explain what happened to LUPIN either. They buying them as well? Think out loud about something else.
If MNK was the buyer then why stop the approval of a drug the partnered on? Clearly they want the revenue. They would just let it go through while working on the deal. It makes no sense.
Why not share your response? Did the Fda swear you to secrecy? Why the games Sprot?
Gluco and Keppra are different. They said in their earnings they are exploring options. So there is your update, no deal yet, they're looking for ways to commercialize.
Focalin was different because they were told they had to redo the Bioequvilance data. A update on that could've been given I agree. But this isn't that scenario. For whatever reason the FDA jumped the gun and posted the "approvals" with out giving ipci their approval letters. If you want someone to tell you they haven't gotten an approval yet call and ask. I'm sure he will tell you they haven't been informed of an approval by the FDA.
We all know it should be coming any day now. It's been 5 business days. If it doesn't come in the near future and they receive some communication from the FDA as per a reason WHY, then maybe there is cause to issue a PR and inform shareholders. But as of now its business as usual until the FDA advises them of anything good or bad.
Sprot expects PR saying "still waiting" lol relax
I'd be lying if I said I knew exactly how the orange book works... Maybe someone else can chime in with more info
We'll fwiw i searched the orange book and found Lupin's seroquel / QUETIAPINE FUMARATE
It appears to be a issue with FDA. I have a feeling it will all be cleared up next week. Time will tell but im not overly worried as long as no one got the approval.
Green close?
Some bigger new institutional ownership positions.
http://www.nasdaq.com/symbol/ipci/institutional-holdings
BMO bought 106,957 shares and Deutsche Bank added another 65,027
Explain to me what you expect them to do sport? If the fda hasn't communicated to them the approval then they can't make an announcement. All the people jumping in premature are now selling likely. It's out of their control.
Can't it be reported to the sec? If so, then maybe someone who has a better understanding on how it works should do so.
I don't know what people really expect management to say. They can't comment on a lot of the questions we have by law or due to negotiations.
If you're talking to several partners you can't come out and say We're talking to the following people. It would sabotage your negotiations.
It's the shotgun approach. It's done with criminal charges. You throw as many as possible giving more room for pleas, deals, etc.
TORONTO, April 10, 2017 (GLOBE NEWSWIRE) -- Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:IPCI) ("Intellipharmaceutics" or the "Company"), a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, today announced that Purdue Pharma L.P., Purdue Pharmaceuticals L.P., The P.F. Laboratories, Inc. (collectively, "Purdue"), Rhodes Technologies, and Grünenthal GmbH (collectively, "plaintiffs") have commenced patent infringement proceedings against the Company in the United States District Court for the District of Delaware in respect of the Company's New Drug Application ("NDA") filing for its Rexista™ product candidate (abuse-deterrent oxycodone hydrochloride extended release tablets) with the United States Food and Drug administration ("FDA").
Intellipharmaceutics had previously filed its NDA for its RexistaTM product candidate on November 24, 2016, relying on the 505(b)(2) regulatory pathway, which allowed us to reference data from Purdue's OxyContin® extended release oxycodone hydrochloride then in the market in the U.S. The RexistaTM application was accepted by the FDA for further review on February 1, 2017. The Company then certified to the FDA that it believed that its RexistaTM product would not infringe any of the sixteen (16) patents owned by one or more of the plaintiffs, or that such patents are invalid, and it so notified the plaintiffs of such certification. On April 7, 2017, the plaintiffs filed the above-noted legal proceedings, alleging that RexistaTM infringes six (6) out of the sixteen (16) patents.
By reason of the commencement of these legal proceedings, the FDA is stayed for 30 months from granting final approval to the Company's RexistaTM abuse-deterrent oxycodone. That time period commenced on February 24, 2017, when the plaintiffs were notified of the Company certification concerning the patents, and will expire on August 24, 2019, unless the stay is earlier terminated by a final declaration of the courts that the patents are invalid, or are not infringed, or the matter is otherwise settled among the parties.
Dr. Isa Odidi, CEO and Co-Chief Scientist of the Company, stated, "Contesting litigation of this nature is part of what it takes to compete for the right to market valuable novel drug products in the United States. We have engaged highly regarded patent counsel with substantial directly applicable experience. We believe that we do not infringe the subject patents and that we have a well-prepared strategy to vigorously defend the Company against these claims."
About Intellipharmaceutics
Intellipharmaceutics International Inc. is a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs. The Company's patented Hypermatrix™ technology is a multidimensional controlled-release drug delivery platform that can be applied to the efficient development of a wide range of existing and new pharmaceuticals. Based on this technology platform, Intellipharmaceutics has developed several drug delivery systems and a pipeline of products (some of which have received FDA approval) and product candidates in various stages of development, including Abbreviated New Drug Application ("ANDAs") filed with the FDA (and one Abbreviated New Drug Submission filed with Health Canada) in therapeutic areas that include neurology, cardiovascular, gastrointestinal tract, diabetes and pain.
Intellipharmaceutics also has NDA 505(b)(2) specialty drug product candidates in its development pipeline. These include Rexista™, an abuse deterrent oxycodone based on its proprietary nPODDDS™ novel Point Of Divergence Drug Delivery System (for which an NDA has been filed with the FDA), and Regabatin™ (pregabalin extended-release capsules). Our current development effort is increasingly directed towards improved difficult-to-develop controlled-release drugs which follow an NDA 505(b)(2) regulatory pathway. The Company has increased its research and development emphasis towards new product development, facilitated by the 505(b)(2) regulatory pathway, by advancing the product development program for both Rexista™ and Regabatin™. The 505(b)(2) pathway (which relies in part upon the approving agency's findings for a previously approved drug) both accelerates development timelines and reduces costs in comparison to NDAs for new chemical entities. An advantage of our strategy for development of NDA 505(b)(2) drugs is that our product candidates can, if approved for sale by the FDA, potentially enjoy an exclusivity period which may provide for greater commercial opportunity relative to the generic ANDA route.
Cautionary Statement Regarding Forward-Looking Information
Certain statements in this document constitute "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995 and/or "forward-looking information" under the Securities Act (Ontario). These statements include, without limitation, statements expressed or implied regarding our plans, goals and milestones, status of developments or expenditures relating to our business, plans to fund our current activities, statements concerning our partnering activities, health regulatory submissions, strategy, future operations, future financial position, future sales, revenues and profitability, projected costs, and market penetration. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "expects," "plans," "plans to," "anticipates," "believes," "estimates," "predicts," "confident", "potential," "continue," "intends," "look forward," "could," or the negative of such terms or other comparable terminology. We made a number of assumptions in the preparation of our forward-looking statements. You should not place undue reliance on our forward-looking statements, which are subject to a multitude of known and unknown risks and uncertainties that could cause actual results, future circumstances or events to differ materially from those stated in or implied by the forward-looking statements. Risks, uncertainties and other factors that could affect our actual results include, but are not limited to, the effects of general economic conditions, securing and maintaining corporate alliances, our estimates regarding our capital requirements, and the effect of capital market conditions and other factors, including the current status of our product development programs, on capital availability, the potential dilutive effects of any future financing and the expected use of any proceeds from any offering of our securities, our ability to maintain compliance with the continued listing requirements of the principal markets on which our securities are traded, our programs regarding research, development and commercialization of our product candidates, the timing of such programs, the timing, costs and uncertainties regarding obtaining regulatory approvals to market our product candidates and the difficulty in predicting the timing and results of any product launches, and the timing and amount of any available investment tax credits, the actual or perceived benefits to users of our drug delivery technologies, products and product candidates as compared to others, our ability to establish and maintain valid and enforceable intellectual property rights in our drug delivery technologies, products and product candidates, the scope of protection provided by intellectual property for our drug delivery technologies, products and product candidates, the actual size of the potential markets for any of our products and product candidates compared to our market estimates, our selection and licensing of products and product candidates, our ability to attract distributors and collaborators with the ability to fund patent litigation and with acceptable product development, regulatory and commercialization expertise and the benefits to be derived from such collaborative efforts, sources of revenues and anticipated revenues, including contributions from distributors and collaborators, product sales, license agreements and other collaborative efforts for the development and commercialization of product candidates, our ability to create an effective direct sales and marketing infrastructure for products we elect to market and sell directly, the rate and degree of market acceptance of our products, delays that may be caused by changing regulatory requirements, the difficulty in predicting the timing of regulatory approval and launch of competitive products, the difficulty in predicting the impact of competitive products on volume, pricing, rebates and other allowances, the inability to forecast wholesaler demand and/or wholesaler buying patterns, the seasonal fluctuation in the numbers of prescriptions written for our Focalin XR® (dexmethylphenidate hydrochloride extended-release) capsules which may produce substantial fluctuations in revenues, the timing and amount of insurance reimbursement regarding our products, changes in laws and regulations affecting the conditions required by the FDA for approval, testing and labeling of drugs including abuse or overdose deterrent properties, and changes affecting how opioids are regulated and prescribed by physicians, changes in laws and regulations, including Medicare and Medicaid, affecting among other things, pricing and reimbursement of pharmaceutical products, the success and pricing of other competing therapies that may become available, our ability to retain and hire qualified employees, the availability and pricing of third party sourced products and materials, challenges related to the development, commercialization, technology transfer, scale-up, and/or process validation of manufacturing processes for our products or product candidates, the manufacturing capacity of third-party manufacturers that we may use for our products, the recoverability of the cost of any pre-launch inventory should a planned product launch encounter a denial or delay of approval by regulatory bodies, a delay in commercialization, or other potential issues, the successful compliance with FDA, Health Canada and other governmental regulations applicable to us and our third party manufacturers' facilities, products and/or businesses, difficulties, delays or changes in the FDA approval process or test criteria for ANDAs and NDAs, challenges in securing final FDA approval for our product candidates, including RexistaTM in particular, as a patent infringement suit has been filed against us, which could delay the FDA's final approval of such product candidates, healthcare reform measures that could hinder or prevent the commercial success of our products and product candidates, the FDA may not approve requested product labeling for our product candidate(s) having abuse-deterrent properties, targeting common forms of abuse (oral, intra-nasal and intravenous), risks associated with cyber-security and the potential for vulnerability of our digital information or the digital information of a current and/or future drug development or commercialization partner of ours, and risks arising from the ability and willingness of our third-party commercialization partners to provide documentation that may be required to support information on revenues earned by us from those commercialization partners. Additional risks and uncertainties relating to us and our business can be found in the "Risk Factors" section of our latest annual information form, our latest Form 20-F, and our latest Form F-3 (including any documents forming a part thereof or incorporated by reference therein), as well as in our reports, public disclosure documents and other filings with the securities commissions and other regulatory bodies in Canada and the U.S., which are available on www.sedar.com and www.sec.gov. The forward-looking statements reflect our current views with respect to future events and are based on what we believe are reasonable assumptions as of the date of this document, and we disclaim any intention and have no obligation or responsibility, except as required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Trademarks used herein are the property of their respective holders.
Unless the context otherwise requires, all references to "we," "us," "our," "Intellipharmaceutics," and the "Company" refer to Intellipharmaceutics International Inc. and its subsidiaries.
Company Contact:
Intellipharmaceutics International Inc.
Domenic Della Penna
Chief Financial Officer
416-798-3001 ext. 106
investors@intellipharmaceutics.com
Investor Contact:
ProActive Capital
Kirin Smith
646-863-6519
ksmith@proactivecapital.com
Right.... What are you up to now? 3,4,$500k? Sure bud.
How's bbd doing too? Done pumping that?
Starting to sound like AAsuited on stocktwits lol
Interesting surge all of a sudden
What day is it again?
It's crazy how quiet this stock is now.. 600 shares trade on tax. 56k on nas. No movement just waiting for news.
Morning all.
Is this today the day? If you listen to impactrader or AAsuited on stocktwits it was yesterday, the day before, the day before that, or so on and so on.
Standing by waiting :P
Bodes well for the hopeful short squeeze. If we could get that rexista partnership news now with a large upfront payment now we would rocket.
To summarize, its a load of crap.
If the author won't put his/her name on it its likely a BS pumping rumor.
Lol yeah wouldn't of even thought of it if it wasn't for those beers
http://adisinsight.springer.com/drugs/800012457
Just a quick search of vasogen autoimmune shows several things they were working on.
Samsa, Is it possible the company used to ATM and now has enough cash to June 2018? It seems like a pretty glaring mistake... With the downward pressure lately I was thinking it could be the reason.
I just don't see MNK buying them out. Why do the partnership deal, upfront cash, negotiations and all, to then turn around and say fawk it lets buy it all?
polyethylene oxide is used in current version of oxyto make it harder to crush is it not? So now all of sudden they're not going to be allowed to use it?
Who's to say that bonus wasn't for the first approved in house. It might of not been specific to that drug.