Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
I looked again at the presentation and I have a comprehension question. It is written:
"New Drug Application (NDA) filed November 2016 (excluding PODRASâ„¢)"
And:
"Rexista® with PODRASâ„¢ granted Fast Track designation by FDA"
Does that mean, their filed NDA for Rexista excluding PODRAS is not on "fast track"?
Sprot, even if you got an answer from the CFO, your interpretation is not based on the given situation. ENDO got an approval, that will benefit IPCI. I would expect ENDO first to announce the approval, befor IPCI could give out a NEWS - but also it is no material information, as ENDO got the approval and will just need to pay IPCI. So maybe we will just read about it in the next Q-results. That's IPCI will benefit from the approval has been shown here in the forum.
"Atria Investments LLC raised its stake in Intellipharmaceutics International Inc. (NASDAQ:IPCI) (TSE:I) by 12.1% during the third quarter, according to its most recent 13F filing with the SEC. The institutional investor owned 75,895 shares of the company’s stock after buying an additional 8,168 shares during the period. Atria Investments LLC owned about 0.26% of Intellipharmaceutics International worth $159,000 as of its most recent filing with the SEC."
Source: http://sleekmoney.com/atria-investments-llc-acquires-8168-shares-of-intellipharmaceutics-international-inc-ipci/1559024.html
see: AC Investor Blog Watchlist for Monday, December 05
"IntelliPharmaCeutics Intl Inc (NASDAQ:IPCI) The stock last week broke out of a descending channel on hourly, after testing support in the $2.7/2.75 region and is now facing resistance at 2.89 area. A break and close above opens the way towards 3.35. From a technical standpoint, the hourly RSI has turned up and is quickly approaching the mid line. The hourly MACD also crossed above its signal line last week. These are positive signals for the stock. $2.89 is the pivot level to watch next week. Im long. I think we could retest the recent highs (3.35) and possibly break upwards some more."
Interesting thought:
"[...] the hearing in 10 days. while that sounds plausible. that is the exact reason I said I didn't believe any good lawyer would ever recommend the company filing the NDA without having details of the deal already ironed out. If IPCI doesn't like the terms they are stuck at this point. By filing they must now submit a manufacture site before the PUDFA date sometime around August. As I stated above, they know they can not fulfill the requirement of finding an approved site by then. if they dont name a site the application stands risking getting rejected. So at this point by them filing they gave away any leverage in any talks with partners. while they are waiting for 10 days for something. I do not believe its them making up their minds. Odidi, may be arrogant as you state but he is no dummy. He would have never risked filing the application and risk having it rejected without knowing a deal is imminent.
I personally can see them waiting 10 days for the partner to transfer the funds or its still being held up waiting on them to actually get Podras patent in hand which should be within that 10 period as well. that would be more logical."
Source: http://www.ipci.ca/post/let-me-tell-you-something-if-ipci-even-considers-8325497
Intellipharmaceutics to Present at the LD Micro Main Event
insert-text-here
"Pipeline of 20 opiate drug candidates with 505(b)(2) potential*"
See Slide 8:
http://files.shareholder.com/downloads/ABEA-43EQSZ/2159629150x8127381x912718/535FA8C8-DD8D-40EC-AAE2-66CE4CC7AD08/Dawson_Securities_Conference_October_20_2016_-_Final.pdf
If you open yesterday's presentation, have a look at the tab in your browser! http://files.shareholder.com/downloads/ABEA-43EQSZ/2159629150x8127381x912718/535FA8C8-DD8D-40EC-AAE2-66CE4CC7AD08/Dawson_Securities_Conference_October_20_2016_-_Final.pdf It's named OXTENDA -> https://trademarks.justia.com/863/94/oxtenda-86394998.html
I just read again the SEC-filling ... and I get more and more excited:
"The Registrant has agreed to manufacture and supply the licensed products exclusively for Mallinckrodt on a cost plus basis, and Mallinckrodt has agreed that the Registrant will be its sole supplier of the licensed products marketed in the U.S."
No more worries about the cash:
"Under the terms of the 10-year agreement, the Registrant will receive a non-refundable upfront payment of US$3 million in October 2016. In addition, the agreement also provides for the Registrant to have a long-term profit sharing arrangement with respect to the licensed products (which includes up to $11 million in cost recovery payments to the Registrant)." http://www.intellipharmaceutics.com/secfiling.cfm?filingid=1654954-16-2764&CIK=1474835
Looking backwards, now I understand why they just made a small PP last spring (although the demand from people to sign the PP was much bigger). They new, that the Seroquel patent will expire Nov 1st. So they could foresee that their tentativ approval will come in Oct and probably they already have a partner waiting for it. It's just my theory, but because of it I don't worry about the low cash. Probably we will hear soon about a Seroquel partnership (maybe even including Keppra).
numbersarefun, I would love to hear from you, what you think IPCI will be able to earn from Seroquel with a good partner!
Obviously, everyone is invited to give projections.
IntelliPharmaCeutics (IPCI) Stock Gaining Big On Generic Approval
http://cnafinance.com/intellipharmaceutics-ipci-stock-gaining-big-on-generic-approval/11411
Ah, I see: https://www.drugpatentwatch.com/p/tradename/EFFEXOR+XR
In general I expect all of IPCI's ANADs to be approved in 2017, as FDA promised to speed up.
Why do you think Effecor XR will be the next approved ANAD? And already since 2010 there are generic version: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm217624.htm - the next big news I am looking foreward is a partnership for Seroquel, that will probably follow quickly now ... and then Rexista.
So, who are the possible partners for IPCI?
Endo has a generic Seroquel and is the firs-to-file: https://www.google.co.il/url?sa=t&rct=j&q=&esrc=s&source=web&cd=5&ved=0ahUKEwja5O3Z6MrPAhVJfhoKHXFWDwMQFgg6MAQ&url=http%3A%2F%2Fphx.corporate-ir.net%2FExternal.File%3Fitem%3DUGFyZW50SUQ9MzM3Mjc3fENoaWxkSUQ9LTF8VHlwZT0z%26t%3D1%26cb%3D635980742099526131&usg=AFQjCNFL5RuCbKSKb7jcCudUAJ6riIJzAg&bvm=bv.135258522,d.d2s&cad=rja
Teva has a generic Seroquel, that they already have in the market in UK: http://www.pmlive.com/pharma_news/generic_seroquel_launched_teva_uk_astrazeneca_nhs_396225
So, who do you think, will stand in line for IPCI's Seroquel? Maybe: Who would be a good partner for a double deal for Keppra and Seroquel?
WNY Opioid Task Force Says Fight to End Addiction is Far From Over
http://www.twcnews.com/nys/buffalo/news/2016/10/3/opioid-task-force-fighting-addiction-wester-new-york.html
Maybe the selling can also be explained by fatigué of long time investors, that are in deep minus and want to "save" their money. If you are pessimistic, you see IPCI running out of money without a partnership at the horizont. Think about it, how the SP develloped since the Keppra-News.
Probably some profit taking. Would be a good sign if IPCI will close above 2,34.
Slow start after all the pre-market action
Real Action:
09:13 $ 2.40 3,500
09:13 $ 2.40 416
09:10 $ 2.43 267
09:10 $ 2.43 100
09:10 $ 2.43 100
09:10 $ 2.43 33
09:09 $ 2.43 87
09:07 $ 2.43 180
09:07 $ 2.43 300
09:07 $ 2.43 100
09:07 $ 2.43 200
09:07 $ 2.43 100
09:07 $ 2.43 120
09:07 $ 2.45 180
09:07 $ 2.45 300
09:07 $ 2.45 300
09:07 $ 2.45 420
09:07 $ 2.43 300
09:04 $ 2.32 213
09:00 $ 2.31 209
Pre-market "action":
09:04 $ 2.32 Volume: 213
09:00 $ 2.31 Volume: 209
Date Close High Low Volume Short Volume % of Vol Shorted
Oct 03 2.25 2.36 2.08 587,800 201,282 34.24%
Sep 30 2.10 2.10 2.00 190,400 58,492 30.72%
Sep 29 2.00 2.06 1.98 127,300 33,906 26.63%
Sep 28 2.03 2.12 1.89 467,500 114,925 24.58%
http://nakedshortreport.com/index.php?index=IPCI
I don't want to be a party pooper, but maybe it is simply the people being short covering?
Pre-market games or are we going to have a good green thursday? Pre-market bid already at 2.05
I already wonderedfrom where he got the "$500 million IP" - so it was simply a typo and he meant "ITCI". So nevermind.
From Twitter:
Tom Walsh
?@measured_moves
At $500 million IP valuation plus cash = price is 21.60 give or take. $IPCI
Very interesting article about the use of colour in abuse-deterrent opioids:
"How Color Measurement of Abuse-Deterrent Opioids Can Enhance Public Health"
http://www.hunterlab.com/blog/color-pharmaceuticals/how-color-measurement-of-abuse-deterrent-opioids-can-enhance-public-health/
And here for everyone IPCI's explanation what RexistaTM XR (oxycodone hydrochloride extended release tablets) is:
"The Company’s Rexista™ XR (oxycodone hydrochloride extended release tablets) product candidate is intended as an abuse and alcohol-deterrent controlled-release oral formulation of oxycodone hydrochloride for the relief of pain. Rexista™ XR is an investigational drug, with a unique long acting oral formulation of oxycodone intended to treat moderate-to-severe pain when a continuous, around the clock opioid analgesic is needed for an extended period of time. The formulation is intended to present a significant barrier to tampering when subjected to various forms of physical and chemical manipulation commonly used by abusers. It is also designed to prevent dose dumping when inadvertently co-administered with alcohol. Dose dumping is the rapid release of an active ingredient from a controlled-release drug into the blood stream that can result in increased toxicity, side effects, and a loss of efficacy. Dose dumping can result by consuming the drug through crushing, taking with alcohol, extracting with other beverages, vaporizing or injecting. In addition, when crushed or pulverized and hydrated, the proposed extended release formulation is designed to coagulate instantaneously and entrap the drug in a viscous hydrogel, which is intended to prevent syringing, injecting and snorting. Our RexistaTM XR formulation contains a blue dye that is emitted once the tablet is tampered with or crushed. The blue dye will stain mucous membranes and skin if the product is manipulated and comes in contact with moisture. This stigmatizing blue dye is intended to act as a visible deterrent against inappropriate use if abused orally or via the intra-nasal route." (Taken from the July 05, 2016 NEWS release: https://globenewswire.com/news-release/2016/07/05/853614/0/en/Intellipharmaceutics-Reports-Update-on-Rexista-XR-FDA-Grants-Waiver-of-NDA-Filing-Fee-and-Topline-Pharmacokinetics-Results-Indicate-No-Food-Effect.html )
WeeZuhl, if someone grinds the pill with a goal of snorting or chewing it, it releases a blue dye that stains the entry point. That's the reason.
Dreaming a second: If we break the resistance at 2,34 the way up is free to 3$ and beyond - to a blue sky!
https://www.thestreet.com/story/13750577/1/changes-at-the-top-for-endo-could-benefit-its-smaller-partners.html
"Changes at the Top for Endo Could Benefit Its Smaller Partners The promotion of Paul Campanelli to CEO indicates a change in the company's focus from acquiring other firms to its roots as a generic pharmaceutical firm.
[...]
Another beneficiary of this recent move by Endo may be its much smaller partner, Intellipharmaceutics International (IPCI), which has a long-standing partnership agreement for the marketing of generic Focalin XR (Dexmethylphenidate hydrochloride extended release), a $760 million in annual sales drug for ADHD. PCI originally signed its deal with Par in 2005 for all dosage strengths of Focalin XR, and while two dosage strengths (15 mg and 30 mg) of the generic were approved by the FDA and launched by Par in November 2013, four more (5, 10, 20 and 40 mg) need additional approval by the agency to meet new regulatory requirements. While IPCI has stated that it is working with Par (now Endo) to obtain the additional approvals, and it is confident Endo will launch as soon as possible, the new emphasis by Endo on operations removes some of the risk of this partnership that may have been perceived after Par was folded into Endo. What's more, IPCI now may find a more focused potential partner in Endo for other products in its pipeline which have yet be partnered. These include two branded (NDA track) drug candidates, seven additional generic drug ANDA applications, and up to 20 opiate drug candidates with potential for the easier 505(b)(2) regulatory approval route with the FDA. While ENDP shares responded favorably today to its news release, IPCI shares surged mysteriously yesterday -- so mysteriously IPCI felt it necessary to issue a press release disavowing knowledge of "any corporate developments that may have caused the recent movement in the company's share price". Perhaps, however, the corporate development providing a boost to IPCI came from partner Endo, instead."
The TA of IPCI looks good. The share price is above the 9,13,20,50,100 and 200 EMA - and the RSI is still okay. So looking foreward for a green week.
And not to forget, Endo had a lot of problems with its opioid painkiller Opana! So IPCI having Rexista and their ANADs would be a perfect fit for Endo.
Some years ago there was already once a buyout rumour - does anyone still have the "source" for the rumour then?
One note to my last post: Against all those thoughts stand the doubt about briefingwire as a source. It is a portal where everyone can post everything he wants. So this could also simply be a very stupid push!
A bit of creative thinking: On Thursday we had this sudden spike in the share price and an updated buyout rumour - and on the next day ENDO International makes the formder CEO of Par Pharmaceuticals, Paul Campanelli, their new CEO. Endo International owns Par Pharmaceuticals and IPCI partned with Par Pharmaceuticals (with Paul Campanelli). So Paul Campanelli is probably quiet well informed about IPCI. So I try the educated guess and say, that maybe the buyout rumour is true and Endo International could be the one who wants to buy IPCI. Already in the past Par Pharmaceuticals had some shares of IPCI, that they sold then later (according to IR), but maybe now Endo International wants a piece or all of the company.
Interesting thoughts on stockwits:
"don't you find it weird $ENDO got a new ceo a day after the activity?"
"$ENDO also removed FDA approval for their opana er just last month"