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Intellipharmaceutics International Inc. (IPCI)

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Last Post: 2/25/2017 12:00:24 PM - Followers: 222 - Board type: Free - Posts Today: 23

FDA Grants Fast Track Designation for Intellipharmaceutics Rexista(TM) Oxycodone XR Incorporating PODRAS(TM) Technology
Full Press Release as follows:    

Intellipharmaceutics has 8 ANDA Drug Applications Filed with the FDA

Intellipharmaceutics has 2 NDA 505(b)product candidates in its development pipeline:
NDA Number 1: Rexista™ Oxycodone XR, an abuse-deterrent oxycodone, based on its proprietary nPODDDS™ novel Point Of Divergence Drug Delivery System
and PODRAS™ Paradoxical OverDose Resistance Activating System
NDA Number 2: Regabatin™ Pregabalin XR, extended-release capsules also based on their proprietary nPODDDS and PODRAS tech platforms

1st ANDA approved by the FDA(FocalinXR) in Nov 2013, partnered with Par with the 1st 2 strengths being sold by PAR awaiting FDA approval on rest of their strengths already slated for full commercialization by PAR
2nd ANDA partnered with TEVA awaiting FDA approval(Speculation is that this is a partnership deal on Seroquel)
 IPCI's Full Product Pipeline:
                                                                Pipeline Chart

IPCI ANNUAL INFORMATION FORM - For the Fiscal Year Ended November 30, 2015
Number of IPCI shares outstanding as of August 31, 2016 = 29 million - fully diluted = 37.4 million
If/when fully diluted @ above $3.55 p/s the 8.4 million option, warrants & convertible debt would add $25,849,000 in cash or an average of $3.07 per share
[email protected]
January 2017 IPCI Investor PRESENTATION
October 2016 IPCI Slide PRESENTATION
October 2016 IPCI Slide Presentation - Slide 24 - Oustanding Shares Info
October 2016 IPCI's Full Pipeline

IPCI Insider and Institutional HOLDINGS SUMMARY

IPCI Press Releases:

IPCI IR contact: [email protected]

Analysts Weigh in on IntelliPharmaCeutics International Inc. (IPCI) as Rexista NDA Pathway Shortened
May 22, 2015 7:02 AM EDT by Jason Cohen, Editor in Healthcare • Insights

Analysts are weighing in on IntelliPharmaCeutics Intl Inc (USA) (NASDAQ:IPCI), following the news that the FDA has provided the company with guidance regarding its abuse-deterrent Rexista Oxycodone XR IND, importantly communicating that the company will not be required to conduct Phase III studies if bioequivalence to Oxycontin is demonstrated.

Brean Capital analyst Jonathan Aschoff believes that Intellipharmaceutics has already demonstrated bioequivalence in its recent submission to the FDA, where top-line data results from three definitive Phase 1 PK trials all have demonstrated the bioequivalence of Rexista and Oxycontin.

Aschoff wrote, “We estimate that the freedom to forego Phase 3 testing will shave off at least $20 million from the cost of development, as well as about 18-24 months of time. The NDA process should now only cost Intellipharmaceutics about $1-1.5 million. We believe that the FDA was satisfied with the bioequivalence data in the IND and thus what remains to be completed prior to NDA submission primarily involves six-month stability testing comparing bioequivalence before and after the six-month period.”

The analyst rates IntelliPharmaCeutics shares a Buy, with an $8 price target, which implies an upside of 172% from current levels.

Additionally, Maxim Group analyst Jason Kolbert spoke with IPCI management and come with the conclusion that bioequivalence has already been demonstrated, and that the management’s confidence that they can meet all the filing requirements is quite high.

Kolbert noted, “This is good news. It shaves off years from our time line and estimates. We need to review the impact to our model and assumptions, suffice to say skipping pivotal trials is positive. We expect a partner to be announced prior to approval. IPCI’s own, high margin, brand product with IP represents the transition of this company to something more than a technical supplier of XR generics.”



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IPCI News: Report of Foreign Issuer (6-k) 02/24/2017 08:06:53 AM
IPCI News: Intellipharmaceutics Announces FDA Approval for 500 mg and 750 mg Generic Glucophage® XR 02/24/2017 08:00:00 AM
IPCI News: Report of Foreign Issuer (6-k) 02/10/2017 08:09:04 AM
IPCI News: Intellipharmaceutics Announces 2016 Year End Results 02/10/2017 08:00:00 AM
IPCI News: Report of Foreign Issuer (6-k) 02/02/2017 05:05:23 PM
#19060  Sticky Note Intellipharmaceutics Signs an Exclusive License and Commercial NASDAQ2020 10/11/16 08:22:05 PM
#24413   Samsa, Novartis does not own Lyrica, Pfizer does. numbersarefun 02/25/17 01:14:38 PM
#24412   Fasten your seat-belts folks and enjoy the ride. ImpactTrader16 02/25/17 12:00:23 PM
#24411   It's not a pump (or at least it fabius 02/25/17 11:38:41 AM
#24410   Samsa, although I would love to believe the fmgrana 02/25/17 11:17:38 AM
#24409   Awfully detailed to be a rumor. smitter 02/25/17 10:59:34 AM
#24408   That could be why got shorted down so low... smitter 02/25/17 10:58:59 AM
#24407   That would be Massive! Noticed the Bid well smitter 02/25/17 10:50:14 AM
#24406   Fabius.....I agree. first, its a rumor. Samsa 02/25/17 10:26:35 AM
#24405   wow...more mindless bashing. what gap? you Samsa 02/25/17 10:15:44 AM
#24404   Wouldn't pay much attention to the rumor...Maybe it fabius 02/25/17 10:13:02 AM
#24403   regarding the rumor.... J_Cali 02/25/17 09:57:21 AM
#24402   Maybe so, but we shall see. :-) rayank 02/25/17 09:54:16 AM
#24401   Yeah good thinking, but sorry I don't know rayank 02/25/17 09:53:42 AM
#24400   Cali I think you are correct. They wouldn't 92662 02/25/17 09:30:25 AM
#24399   Nope. Needs to fill the gap at $2.32 wiping aELmTPa 02/25/17 09:05:18 AM
#24398   If the rumor was true. 10 million in CIronman 02/25/17 09:04:09 AM
#24397   $2.50 new support now hopefully? :-) rayank 02/25/17 08:28:57 AM
#24396   You got his number Mopar! Coincidence.....I don't TriumphTR8 02/25/17 08:28:29 AM
#24395   Stockcharts @ IPCI Investor100 02/25/17 08:27:03 AM
#24394   Here is the source mopar. I posted it rayank 02/25/17 08:26:51 AM
#24393   So we can blame them if false rumor. LOL rayank 02/25/17 08:17:07 AM
#24392   I'd say that's more of a leak than A1stockman 02/25/17 07:41:30 AM
#24391 Again posted by spiderpr... mopar44o 02/25/17 02:20:14 AM
#24390   Intellipharmaceutics is expected to sign a $60 million Avoid 02/24/17 10:58:31 PM
#24389   The rumor looks like it hit late in wimike 02/24/17 08:49:40 PM
#24388   Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:I) ("Intellipharmaceu NASDAQ2020 02/24/17 08:00:03 PM
#24387   I would say the three names mentioned are J_Cali 02/24/17 06:48:50 PM
#24386   Appreciate the clarification, Angelo. I just trade fmgrana 02/24/17 06:10:52 PM
#24385   Yes, interesting action as the move up to AngeloFoca 02/24/17 06:01:33 PM
#24384   Stuck at work I can only log on Aloha922 02/24/17 05:59:58 PM
#24383   I'm far from an expert on stock trading mopar44o 02/24/17 05:56:19 PM
#24382   Mopar, I will say that the volume this Tekterra 02/24/17 05:52:32 PM
#24381   They timed it well today. If this Tekterra 02/24/17 05:50:54 PM
#24380   We didn't get stopped because there was a mopar44o 02/24/17 05:44:53 PM
#24379   That source is only as reliable as the mopar44o 02/24/17 05:42:45 PM
#24378   Yes, interesting action as the move up to fmgrana 02/24/17 05:42:30 PM
#24377   Geee... Another rumor posted on a site with mopar44o 02/24/17 05:39:18 PM
#24376   Lol mopar44o 02/24/17 05:29:42 PM
#24375   Well moving up AH... 2.70-2.72 now declaes 02/24/17 04:49:14 PM
#24374   Just life in the market Fabius. Those Tekterra 02/24/17 04:39:57 PM
#24373   * * $IPCI Video Chart 02-24-17 * * ClayTrader 02/24/17 04:38:35 PM
#24372   Keppra_XR ANDA approval announced 2/24/2016, what a coincidence. numbersarefun 02/24/17 04:32:51 PM
#24371   Why with last rumor we got the trading fabius 02/24/17 04:26:14 PM
#24370   Lol, I would call this a pump. Tekterra 02/24/17 04:20:23 PM
#24369   You too! SMART smitter 02/24/17 04:13:07 PM
#24368   I was going to bring up the Novartis chainma1l 02/24/17 04:11:49 PM
#24367   over 5m volume is very serious accumulation [SMART MONEY] 02/24/17 04:11:07 PM
#24366   Source of rumor: SpiderPR rayank 02/24/17 04:00:12 PM
#24365   Novartis is on short list for Rexista given fabius 02/24/17 03:52:59 PM
#24364   Many many moons ago... I did some research AngeloFoca 02/24/17 03:42:52 PM