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Intellipharmaceutics International Inc. (IPCI)

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Last Post: 3/24/2017 6:54:30 AM - Followers: 223 - 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) 03/21/2017 06:06:50 AM
IPCI News: Report of Foreign Issuer (6-k) 03/16/2017 08:09:29 AM
IPCI News: Intellipharmaceutics Announces TSX Trading Symbol Change to “IPCI” 03/16/2017 08:00:00 AM
IPCI News: Annual and Transition Report (foreign Private Issuer) (20-f) 02/28/2017 06:23:10 PM
IPCI News: Report of Foreign Issuer (6-k) 02/28/2017 05:01:51 PM
PostSubject
#19060  Sticky Note Intellipharmaceutics Signs an Exclusive License and Commercial NASDAQ2020 10/11/16 08:22:05 PM
#25472   Doog....you beat me to it. I agree. Samsa 03/24/17 06:54:30 AM
#25471   I would concur...just more craziness elvisonfire 03/24/17 03:39:56 AM
#25470   To summarize, its a load of crap. mopar44o 03/23/17 04:32:23 PM
#25469   Running it too tight is what cost them doogdilinger 03/23/17 04:00:05 PM
#25468   We'll have to see Doog. Their annual Tekterra 03/23/17 03:55:27 PM
#25467   Agreed Tek...a lot of the valuation metrics are doogdilinger 03/23/17 03:37:17 PM
#25466   Yeah, I find that surprising he assign zero Tekterra 03/23/17 03:33:47 PM
#25465   Any further expensive R&D on Regabatin and PODRAS doogdilinger 03/23/17 03:32:38 PM
#25464   lol yep shows how completely out to lunch doogdilinger 03/23/17 03:23:38 PM
#25463   Yeah, apparently there some obvious mistakes. However, Tekterra 03/23/17 03:22:43 PM
#25462   bbhuey- Yep everyone was talking about that this wimuskyfisherman 03/23/17 03:15:12 PM
#25461   He said because they have no partner it wimuskyfisherman 03/23/17 03:14:11 PM
#25460   I think eorxnews.com had some news that ipci bbhuey 03/23/17 02:59:37 PM
#25459   Exactly plus the moron ascribed ZERO value whatsoever doogdilinger 03/23/17 02:58:49 PM
#25458   doog- That article was absolutely pathetic and showed wimuskyfisherman 03/23/17 02:55:10 PM
#25457   He has next to no followers on seekingalpha doogdilinger 03/23/17 02:49:47 PM
#25456   He's projecting FocalinXR revenues to be a paltry doogdilinger 03/23/17 02:44:34 PM
#25455   Tek- Thanks for sharing that article. It did wimuskyfisherman 03/23/17 02:40:20 PM
#25454   100% agreed! doogdilinger 03/23/17 02:38:36 PM
#25453   haha agreed wimusky...will be an awesome day here doogdilinger 03/23/17 02:37:51 PM
#25452   100% agreed with every single thing you just doogdilinger 03/23/17 02:36:21 PM
#25451   lol agreed bro...looking forward to the days when doogdilinger 03/23/17 02:33:51 PM
#25450   Sam, take a look at this one to Tekterra 03/23/17 01:56:19 PM
#25449   Things needs to change for sure. Unfortunately Tekterra 03/23/17 01:43:39 PM
#25448   WoW, that's only 250km away. Let's make a sprot 03/23/17 01:43:00 PM
#25447   At the very western part near the border cysonic 03/23/17 01:24:59 PM
#25446   Maybe we should meet when this ever would sprot 03/23/17 01:20:45 PM
#25445   It was definitely done by an amateur in chainma1l 03/23/17 01:20:27 PM
#25444   So many?! There is one main discussion board cysonic 03/23/17 01:19:50 PM
#25443   Wim....I know! we probably have the Samsa 03/23/17 01:17:48 PM
#25442   Cysonic- Why are there so many German investors wimuskyfisherman 03/23/17 01:15:44 PM
#25441   Samsa- Indeed there is literally no value assigned wimuskyfisherman 03/23/17 01:11:05 PM
#25440   The website is not from Germany! See: cysonic 03/23/17 01:08:51 PM
#25439   Tekterra.....when I say priced higher I still am Samsa 03/23/17 01:00:00 PM
#25438   Doog....I agree 100%. I loved Samsa 03/23/17 12:49:40 PM
#25437   Markets up across the board. Gold down. Expectation Noodle2 03/23/17 11:31:10 AM
#25436   With the rumor coming up, I don't think Tekterra 03/23/17 11:01:34 AM
#25435   Doog this stuff is illegal, but people do Tekterra 03/23/17 10:57:18 AM
#25434   Sam you keep saying the stock should be Tekterra 03/23/17 10:44:11 AM
#25433   No one buying the rumor news. Noodle2 03/23/17 10:39:07 AM
#25432   Yeah, Teva was taking a huge hit since Tekterra 03/23/17 10:36:31 AM
#25431   Hebrew, it feels like they hit the 2.2 Tekterra 03/23/17 10:34:07 AM
#25430   wimike- I am not much of a trader wimuskyfisherman 03/23/17 10:19:22 AM
#25429   If there's a delay in trading and it Noodle2 03/23/17 10:11:02 AM
#25428   I think the person posting these rumors is chainma1l 03/23/17 09:38:48 AM
#25427   I would guess the "rumour" was written by Hebrew 03/23/17 09:06:42 AM
#25426   lets just say something is at play here. doogdilinger 03/23/17 08:13:52 AM
#25425   Agreed mopar...ever since the 1st fake PR the doogdilinger 03/23/17 08:09:53 AM
#25424   100% agreed Samsa...sick and twisted isn't it sigh! doogdilinger 03/23/17 08:07:39 AM
#25423   I'd love to see the scammers that keep doogdilinger 03/23/17 08:05:30 AM
PostSubject