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Intellipharmaceutics International Inc. (IPCI)

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Last Post: 1/21/2017 11:22:13 AM - Followers: 221 - Board type: Free - Posts Today: 2




FDA Grants Fast Track Designation for Intellipharmaceutics Rexista(TM) Oxycodone XR Incorporating PODRAS(TM) Technology
Full Press Release as follows:
http://ih.advfn.com/p.php?pid=nmona&article=67015971    

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

http://data.cnbc.com/quotes/IPCI/tab/8

 
IPCI Press Releases:

http://www.intellipharmaceutics.com/releases.cfm


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) 01/06/2017 08:17:02 AM
IPCI News: Intellipharmaceutics Reports on Launch of Additional Strengths of Generic Focalin XR® by Par Pharmaceutical 01/06/2017 08:00:00 AM
IPCI News: Report of Foreign Issuer (6-k) 12/29/2016 08:03:26 AM
IPCI News: Intellipharmaceutics to Present at the Biotech Showcase™ 12/29/2016 08:00:00 AM
IPCI News: Report of Foreign Issuer (6-k) 12/21/2016 08:08:53 AM
PostSubject
#20187  Sticky Note This is convenient to have readily available. AngeloFoca 11/12/16 04:55:39 PM
#19060  Sticky Note Intellipharmaceutics Signs an Exclusive License and Commercial NASDAQ2020 10/11/16 08:22:05 PM
#22261   Niiiiiiiice Noodle and thanks for the due NASDAQ doogdilinger 01/21/17 11:22:13 AM
#22258   And, one of the speakers is...Intellipharmaceutics' own, Isa Odidi. Noodle2 01/20/17 09:25:54 PM
#22257   FDA meeting in March NASDAQ2020 01/20/17 08:30:02 PM
#22256   2017 Abusers Deterrent Formulations Summit coming up. NASDAQ2020 01/20/17 08:26:37 PM
#22254   ImpactTrader...I though it was you buying at the wimike 01/20/17 05:08:58 PM
#22253   I loaded up another 50K shares today and ImpactTrader16 01/20/17 04:11:19 PM
#22252   Yeah and at $2.64. :-) rayank 01/20/17 04:04:12 PM
#22251   OK, I see it on the chart now. AngeloFoca 01/20/17 03:59:31 PM
#22250   You too doog. Maybe better next week? rayank 01/20/17 03:55:06 PM
#22249   Agreed Hondo! Have a great weekend all:) doogdilinger 01/20/17 03:50:39 PM
#22248   Yes If we are not to be swallowed hondobud 01/20/17 03:46:48 PM
#22247   hade the same thougts xr_biotech_consult 01/20/17 03:45:26 PM
#22246   If/when IPCI becomes the next PCYC type mover...these doogdilinger 01/20/17 03:44:17 PM
#22245   I have wondered that myself...there's so many moving doogdilinger 01/20/17 03:43:12 PM
#22244   Hey reflecting on the share price of late, hondobud 01/20/17 03:41:08 PM
#22243   Thank you Tekterra...we are in a true life doogdilinger 01/20/17 03:39:43 PM
#22242   What was that??? AngeloFoca 01/20/17 03:34:43 PM
#22241   Buy more IPCI! Who wants to be out hondobud 01/20/17 03:25:05 PM
#22240   The solution is that kind of partnership Angelo fabius 01/20/17 03:20:54 PM
#22239   Purdue needs a technology IPCI has. They know cysonic 01/20/17 02:44:10 PM
#22238   The original buyout rumor was that Odidi gets Tekterra 01/20/17 02:37:19 PM
#22237   I've thought the same thing too. I Tekterra 01/20/17 02:17:45 PM
#22236   Brilliant Angelo! doogdilinger 01/20/17 02:16:56 PM
#22235   Perhaps the issue is not so much agreeing AngeloFoca 01/20/17 02:04:57 PM
#22234   FYI... There are 949 January $2.50 call contracts expiring AngeloFoca 01/20/17 01:52:59 PM
#22233   Exactly Angelo...no-one knows what's going on behind the doogdilinger 01/20/17 01:47:02 PM
#22232   “OxyContin may be the poster child, but it’s doogdilinger 01/20/17 01:38:34 PM
#22231   Around January/February of 2016 the Purdue CEO stated AngeloFoca 01/20/17 01:37:29 PM
#22230   Purdue Pharma Canada and IPCI both HQ'd in doogdilinger 01/20/17 01:32:11 PM
#22229   Angelo....You could be correct as he filed with wimike 01/20/17 01:16:16 PM
#22228   there has not been any insider trading recentlyIf AngeloFoca 01/20/17 12:34:10 PM
#22227   Good info cysonic...I just want to quickly point doogdilinger 01/20/17 12:15:13 PM
#22226   I agree with you Cy. sprot 01/20/17 11:48:00 AM
#22225   Yes, that's possible for sure. But that's a cysonic 01/20/17 11:44:02 AM
#22224   Speculation about potential Purdue lawsuit over IPCI's Rexista doogdilinger 01/20/17 11:29:00 AM
#22223   All I can say is when you have Despicable_Z 01/20/17 11:21:43 AM
#22222   One BIG reason more for Purdue to partner/buy IPCI... fabius 01/20/17 11:19:00 AM
#22221   It would be a game changing year of doogdilinger 01/20/17 11:05:26 AM
#22220   Awesome cysonic...hopefully that site disappears too doogdilinger 01/20/17 11:04:03 AM
#22219   Washington city to sue maker of OxyContin (Purdue) littleguy25 01/20/17 11:02:35 AM
#22218   Indeed and true! sprot 01/20/17 10:49:43 AM
#22217   Form Purdue point of view...that's the strategic move fabius 01/20/17 10:48:07 AM
#22216   Same for acceptance with the plus that you fabius 01/20/17 10:44:23 AM
#22215   Ever thought about a rejection! That will make sprot 01/20/17 10:38:42 AM
#22214   ;-) The stock will go nowhere until we get cysonic 01/20/17 10:31:12 AM
#22213   I would not be shocked if Purdue ends Biotech junkie 01/20/17 10:30:18 AM
#22212   :) Cysonic, at these levels i certainly won't sell. sprot 01/20/17 10:28:26 AM
#22211   Is he or she legitimate? Or has some LGviolet 01/20/17 10:19:50 AM
#22210   In the forum ipci.ca "PHARMER-GUY" just posted: cysonic 01/20/17 10:01:12 AM
#22209   Just google "oxicontin" and "patent" and you will find: cysonic 01/20/17 09:49:57 AM
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