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Intellipharmaceutics International Inc. (IPCI)

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Last Post: 7/22/2017 1:33:29 PM - Followers: 228 - Board type: Free - Posts Today: 0




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
Drugs@FDA
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: investors@intellipharmaceutics.com



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: Prospectus Filed Pursuant to Rule 424(b)(5) (424b5) 07/18/2017 05:16:10 PM
IPCI News: Prospectus Filed Pursuant to Rule 424(b)(5) (424b5) 07/18/2017 05:11:46 PM
IPCI News: Prospectus Filed Pursuant to Rule 424(b)(3) (424b3) 07/18/2017 06:05:11 AM
IPCI News: Notice of Effectiveness (effect) 07/18/2017 06:01:45 AM
IPCI News: Securities Registration (foreign Private Issuer) (f-3/a) 07/14/2017 05:28:08 PM
PostSubject
#19060  Sticky Note Intellipharmaceutics Signs an Exclusive License and Commercial NASDAQ2020 10/11/16 08:22:05 PM
#28332   IPCI @ Stockcharts Investor100 07/22/17 01:33:29 PM
#28331   thank you for the information. This is my AngelofDeath1 07/22/17 08:44:54 AM
#28330   Have a good weekend all. We gear up Despicable_Z 07/21/17 05:28:05 PM
#28329   Thanks for the clarification Samsa. I wouldn't be Despicable_Z 07/21/17 05:27:01 PM
#28328   Angel.....your slightly confused. What doog told you Samsa 07/21/17 04:54:47 PM
#28327   Hope somebody can help me understand why are AngeloFoca 07/21/17 04:41:04 PM
#28326   Doog....yes, same to you, have a great weekend. Samsa 07/21/17 04:40:23 PM
#28325   Then they should be able to market even AngelofDeath1 07/21/17 04:30:29 PM
#28324   Have a great weekend Samsa and IPCI longs...bring doogdilinger 07/21/17 03:56:51 PM
#28323   FDA can still grant tentative approval on the doogdilinger 07/21/17 03:48:15 PM
#28322   Hope somebody can help me understand why are AngelofDeath1 07/21/17 03:25:01 PM
#28321   Thanks Ray hope you're enjoyin' your summer and doogdilinger 07/21/17 09:48:37 AM
#28320   Gotta luv the spreads yesterday into this morn lol doogdilinger 07/21/17 09:47:57 AM
#28319   Yes they can definitely get halted during AdCom's...no doogdilinger 07/21/17 09:46:53 AM
#28318   i'm sorry if this question has been answered cdnrx 07/21/17 08:39:03 AM
#28317   Yes. stocking4ms 07/20/17 06:11:53 PM
#28316   Assuming a positive panel review from AdCom on tongway 07/20/17 05:43:16 PM
#28315   Ok sounds good for you and all the rayank 07/20/17 04:37:51 PM
#28314   Churnin' out the short term profit takers ahead doogdilinger 07/20/17 02:57:03 PM
#28313   And yes no-one can deny Dr Odidi's science doogdilinger 07/20/17 02:53:19 PM
#28312   Just telling it as it is LOL. I doogdilinger 07/20/17 02:49:45 PM
#28311   Doog.....don't get me started on those LOL....you know Samsa 07/20/17 02:39:33 PM
#28310   Yes, had the FDA's generics backlog of the doogdilinger 07/20/17 01:24:12 PM
#28309   Hi Ray thanks buddy...the generics pipeline stall of doogdilinger 07/20/17 01:21:02 PM
#28308   No love for Keppra or Glucophage. How disheartening. chainma1l 07/20/17 01:19:32 PM
#28307   Hi my old friend. Since I got out rayank 07/20/17 01:08:49 PM
#28306   Bring on the next sequence of catalysts>>> doogdilinger 07/20/17 12:53:40 PM
#28305   Stocks Making: Boomer Buy Setup on 2017-07-19 doogdilinger 07/20/17 09:56:37 AM
#28304   Nice find thnx illmatix>>> 12 institutional investors are doogdilinger 07/20/17 09:32:28 AM
#28303   http://www.postanalyst.com/2017/07/20/12-institutional-investors-are-raisin illmatix 07/20/17 09:27:08 AM
#28302   Agreed Angelo:) doogdilinger 07/20/17 08:14:53 AM
#28301   The committees will be asked to discuss AngeloFoca 07/19/17 04:44:08 PM
#28300   Yes, the dossier should indicate the issues/questions the fred198484 07/19/17 04:28:29 PM
#28299   investorshub.advfn.com/uimage/uploads/2017/2/6/ddflcmarch-7th-8th2.jpg[/c doogdilinger 07/19/17 03:58:52 PM
#28298   Could be in store for one HOT month doogdilinger 07/19/17 03:57:02 PM
#28297   Thanks guys.....just wondering. Samsa 07/19/17 03:54:23 PM
#28296   Gotta luv the much higher dollar volume in doogdilinger 07/19/17 03:53:43 PM
#28295   Same for me Samsa doogdilinger 07/19/17 03:52:30 PM
#28294   I would think as long as they say doogdilinger 07/19/17 03:51:49 PM
#28293   Fred....so the dossier will clarify those types of Samsa 07/19/17 03:47:32 PM
#28292   I see that it does say whether the Samsa 07/19/17 03:45:26 PM
#28291   Excellent fred doogdilinger 07/19/17 03:44:32 PM
#28290   I don't think we can know for sure fred198484 07/19/17 03:23:55 PM
#28289   Samsa as I understand it, a positive panel doogdilinger 07/19/17 03:23:12 PM
#28288   That is my biggest concern, wording and interpretation Aloha922 07/19/17 03:11:11 PM
#28287   Doog ....exciting times are sure to come. Samsa 07/19/17 03:06:30 PM
#28286   Wakey wakey IPCI players...by this time next week doogdilinger 07/19/17 02:58:20 PM
#28285   Golden Cross approaching as we get closer to doogdilinger 07/19/17 10:55:09 AM
#28284   IPCI accumulation continues>>> doogdilinger 07/19/17 10:52:36 AM
#28283   Congratz buddy...we're set up for a stellar back doogdilinger 07/19/17 10:31:12 AM
PostSubject