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Intellipharmaceutics International Inc. (IPCI)

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Last Post: 9/25/2016 7:54:53 PM - Followers: 187 - 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:    

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:

IPCI number of shares outstanding as of May 31, 2015: 23,624,311

IPCI Insider and Institutional HOLDINGS SUMMARY

IPCI Press Releases:

IPCI IR contact:

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) 09/22/2016 04:11:23 PM
IPCI News: Intellipharmaceutics Responds to Recent Trading Activity 09/22/2016 04:06:08 PM
IPCI News: Report of Foreign Issuer (6-k) 09/13/2016 02:06:34 PM
IPCI News: Report of Foreign Issuer (6-k) 08/25/2016 04:01:43 PM
IPCI News: Intellipharmaceutics to Present at the 18th Annual Rodman & Renshaw Global Investment Conference 08/25/2016 04:00:00 PM
#16824  Sticky Note IPCI...Chart..Bullish move taking place here for big dollars...imo... georgie18 08/01/16 10:53:05 AM
#18262   Doog....not sure why you keep engaging him? Samsa 09/25/16 07:03:38 PM
#18260   Though excipients were at one time assumed to doogdilinger 09/25/16 06:31:02 PM
#18259   The objective readers of this board are all doogdilinger 09/25/16 06:20:42 PM
#18258   Objective observers are not having a problem. WeeZuhl 09/25/16 05:17:20 PM
#18257   Total and complete HOGWASH!!! How many times must doogdilinger 09/25/16 04:55:44 PM
#18256   WOW, ethical nightmare ! Ha,ha,hahahahahahahahaha. Savage_ 09/25/16 04:48:04 PM
#18255   Any legit user would be well below the WeeZuhl 09/25/16 04:43:01 PM
#18254   It did make for some hilarious reading this doogdilinger 09/25/16 04:13:17 PM
#18253   lmfao no-one's in denial...we're just not braindead hahahahahhaa doogdilinger 09/25/16 04:11:56 PM
#18252   Being held up by the FDA? They haven't mopar44o 09/25/16 04:09:11 PM
#18251   Any legit user would be well below the mopar44o 09/25/16 04:01:06 PM
#18250   More like BAIL OUT negotiations... WeeZuhl 09/25/16 03:29:34 PM
#18249   An easy experiment. WeeZuhl 09/25/16 02:58:54 PM
#18244   Try as you may try as you might doogdilinger 09/25/16 12:36:28 PM
#18243   You require remediation on food dyes. WeeZuhl 09/25/16 12:33:39 PM
#18242   Buy out negotiations may be the best explanation Biotech junkie 09/25/16 12:20:08 PM
#18241   100% pure and utter nonsense as the FDA's doogdilinger 09/25/16 12:13:53 PM
#18240   The facts are clear. WeeZuhl 09/25/16 12:10:40 PM
#18239   lmfao IPCI isn't manufacturing feeding tubes...and the 20 doogdilinger 09/25/16 11:55:12 AM
#18238   100% Complete Confidence WeeZuhl 09/25/16 11:49:47 AM
#18237   For those living in the real world here's doogdilinger 09/25/16 11:19:10 AM
#18236   Again 100% complete nonsense and blatantly false doogdilinger 09/25/16 11:05:41 AM
#18234   Endo wouldn't touch Rexista with a ten-foot pole. WeeZuhl 09/25/16 10:23:10 AM
#18233   And not to forget, Endo had a lot ahasja 09/25/16 06:44:33 AM
#18232   Some years ago there was already once a ahasja 09/25/16 04:23:59 AM
#18231   One note to my last post: Against all ahasja 09/25/16 03:15:00 AM
#18230   A bit of creative thinking: On Thursday we ahasja 09/25/16 02:40:44 AM
#18229   Squirrel would have been a better pick! Biotech junkie 09/25/16 02:37:54 AM
#18227   Pure and complete HOGWASH ie: We stopped feeding doogdilinger 09/24/16 11:56:24 PM
#18226   You're citing a friggin' 13 year old FDA report WeeZuhl 09/24/16 09:31:34 PM
#18225   Oh, I've seen it. BIG problems here. WeeZuhl 09/24/16 07:28:56 PM
#18224   lmfao try reading their recently released food effects PR doogdilinger 09/24/16 07:14:40 PM
#18223   Want to be part of human experiments? WeeZuhl 09/24/16 07:09:09 PM
#18222   No prob Bjdev...we know from IPCI IR and doogdilinger 09/24/16 06:23:54 PM
#18221   Absolute total and complete HOGWASH!!! You're citing a doogdilinger 09/24/16 06:07:56 PM
#18220   Rexista's Blue Dye Problem WeeZuhl 09/24/16 05:48:35 PM
#18219   I didn't mean to imply credibility when I Bjdev89 09/24/16 05:29:06 PM
#18218   It's not interesting whatsoever...IPCI's already done extensive BE doogdilinger 09/24/16 04:32:05 PM
#18217   lmfao talk about DESPERATE!!! Last I checked IPCI's doogdilinger 09/24/16 04:09:43 PM
#18216   That's interesting speculation. But nothing has been referenced Bjdev89 09/24/16 03:12:01 PM
#18215   Interesting thoughts on stockwits: ahasja 09/24/16 03:04:16 PM
#18214   Rexista users could turn blue and die. WeeZuhl 09/24/16 02:13:27 PM
#18213   They're just making sure it's checked/analyzed both internally doogdilinger 09/24/16 12:24:29 PM
#18212   I would not be surprised that the Odidi's declaes 09/24/16 11:24:18 AM
#18211   Good article on leaks - statistics/why they happen/etc. Bjdev89 09/24/16 11:01:34 AM
#18210   Has there ever been an explanation for the Bjdev89 09/24/16 10:49:07 AM
#18209   A BNN TV interview from 2 years ago doogdilinger 09/24/16 07:15:58 AM
#18208   I also would like to know, where Odidi ahasja 09/24/16 07:05:30 AM
#18207   When did Ododi say he wouldn't sell under declaes 09/24/16 05:50:27 AM
#18206   Drugmakers, allies fight efforts to limit opioid prescriptions ahasja 09/24/16 02:50:09 AM