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Intellipharmaceutics International Inc. (IPCI)

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Last Post: 12/10/2016 8:37:15 AM - Followers: 217 - 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
Drugs@FDA
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: Report of Foreign Issuer (6-k) 11/29/2016 08:08:02 AM
IPCI News: Intellipharmaceutics to Present at the LD Micro Main Event 11/29/2016 08:00:00 AM
IPCI News: Report of Foreign Issuer (6-k) 11/25/2016 07:50:41 AM
IPCI News: Intellipharmaceutics Submits New Drug Application for Rexista® (oxycodone hydrochloride extended release), an Abuse Deterren... 11/25/2016 07:45:00 AM
IPCI News: Report of Foreign Issuer (6-k) 10/14/2016 09:04:57 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
#18297  Sticky Note Great article from The Street. Brings lots of hondobud 09/26/16 10:05:20 AM
#21072   An AH sell or buy must cost a Noodle2 12/10/16 08:37:15 AM
#21071   How is it that a 100 shares sold tjguy 12/10/16 08:32:49 AM
#21070   After hours is not run like day trading 92662 12/09/16 09:24:30 PM
#21069   After Hours $2.72. How is it that a Noodle2 12/09/16 07:47:54 PM
#21068   I'm overseas right now, but that is still tjguy 12/09/16 06:41:55 PM
#21067   TJ...oh wow!!!! Yes, that's the Samsa 12/09/16 06:39:08 PM
#21066   OT: Samsa, is that York, PA? tjguy 12/09/16 06:13:27 PM
#21064   Numbers......doesn't the fact that Rexista is being labeled Samsa 12/09/16 05:26:00 PM
#21063   I believe going forward, that the share price Noodle2 12/09/16 05:18:50 PM
#21062   AngeloFoca, IPCI no studies showing superiority over Oxycontin. numbersarefun 12/09/16 04:49:05 PM
#21061   Collegium Xtampza Needs to be administered with Food, AngeloFoca 12/09/16 04:23:56 PM
#21060   good point Tekterra- don't forget COLL has to cdnrx 12/09/16 04:05:58 PM
#21059   I believe the food effect is the biggest fred198484 12/09/16 04:04:42 PM
#21058   Speaking of competitions, Rexista will be competing with Tekterra 12/09/16 03:43:16 PM
#21057   Yes, I was just pointing out progress is dtstx 12/09/16 03:29:25 PM
#21056   Glucophage XR has a huge $2.4 Billion market. AngeloFoca 12/09/16 03:24:26 PM
#21055   Right now EGLT and IPCI both have an Tekterra 12/09/16 03:07:43 PM
#21054   Excellent, thanks for staying on top of the doogdilinger 12/09/16 02:58:21 PM
#21053   Impact.....I know the company is in Toronto. Samsa 12/09/16 02:27:50 PM
#21052   "The disastrous tally has been pushed to new Noodle2 12/09/16 02:01:10 PM
#21051   Where is our company situated? Toronto ImpactTrader16 12/09/16 02:00:28 PM
#21050   Well.....I'm in York Pa. right now ! I Samsa 12/09/16 01:48:35 PM
#21049   Locked and Loaded my friends ...been ready for ImpactTrader16 12/09/16 01:28:10 PM
#21048   well..i´m in Hamburg, Germany right now something will scapaflow 12/09/16 01:08:08 PM
#21047   YOU MIGHT WANT TO HOLD ON TO YOUR ImpactTrader16 12/09/16 01:02:13 PM
#21046   Very true. smitter 12/09/16 12:53:26 PM
#21045   Approval given (2) days ago to another company dtstx 12/09/16 12:43:46 PM
#21044   Probably shorted it knowing that the news was Garden Rose 12/09/16 12:26:05 PM
#21043   Could also be Shorts starting to quietly Cover! smitter 12/09/16 12:23:24 PM
#21042   That's why I've been saying that price is Garden Rose 12/09/16 12:22:54 PM
#21041   Fabius.....I actually think PAR could have started and Samsa 12/09/16 12:22:20 PM
#21040   NICE!!!! Next week then we could see Big News! smitter 12/09/16 12:18:49 PM
#21039   Letter from FDA dated 11/30/16 Garden Rose 12/09/16 12:06:34 PM
#21038   When was this letter? This is Great News! smitter 12/09/16 12:05:37 PM
#21037   honestly I don't know. fabius 12/09/16 12:01:49 PM
#21036   Fab is this why price is moving upwards Garden Rose 12/09/16 11:56:23 AM
#21035   Great, this is what I was referring to fabius 12/09/16 11:42:23 AM
#21034   The credit goes to Biotech Junkie who posted 92662 12/09/16 10:57:21 AM
#21033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202842Orig1s000ltr. 92662 12/09/16 10:55:09 AM
#21032   Garden we all know stock players are out Tekterra 12/09/16 10:53:21 AM
#21031   fabius, I truly believe the company is working Garden Rose 12/09/16 10:04:56 AM
#21030   Excellent day for $ IPCI smitter 12/09/16 09:54:53 AM
#21029   Fabius.......I agree with your assertions regarding the short Samsa 12/09/16 09:28:31 AM
#21028   Page 4 talks about FDA Priorities!!!! Not much Aloha922 12/09/16 09:25:41 AM
#21027   Samsa, regarding Focalin I think we could only fabius 12/09/16 09:00:33 AM
#21026   I thought I would be getting on here Samsa 12/09/16 08:21:53 AM
#21025   Well I'm not numbers but perhaps I can dtstx 12/08/16 09:15:41 PM
#21024   The probable cause for the drop yesterday. Frankly, Noodle2 12/08/16 06:09:12 PM
#21023   Tek, thanks. tjguy 12/08/16 05:59:53 PM
#21022   http://www.nbcnews.com/business/business-news/pfizer-fined-over-100m-hiking-epil Noodle2 12/08/16 04:00:20 PM
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