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Intellipharmaceutics International Inc. (IPCI)

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Last Post: 8/21/2017 11:33:46 AM - Followers: 229 - 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
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: READ NOW: Monteverde & Associates PC Invites IntelliPharmaCeutics International Inc. Shareholders with Losses in Excess of $1... 08/15/2017 04:52:00 PM
IPCI News: Report of Foreign Issuer (6-k) 08/08/2017 03:06:36 PM
IPCI News: Intellipharmaceutics Announces Resignation of Chief Financial Officer 08/08/2017 03:00:00 PM
IPCI News: Report of Foreign Issuer (6-k) 07/31/2017 08:10:21 AM
IPCI News: Intellipharmaceutics Intends to Vigorously Defend Recently Filed Purported Class Action Lawsuit 07/31/2017 08:00:00 AM
PostSubject
#19060  Sticky Note Intellipharmaceutics Signs an Exclusive License and Commercial NASDAQ2020 10/11/16 08:22:05 PM
#29489   Angelo- Are you saying that the oral and wimuskyfisherman 08/21/17 11:33:46 AM
#29488   mopar....agree the price of the FDA refusal to wimike 08/21/17 01:27:09 AM
#29487   It's possible. I don't see it falling much. mopar44o 08/20/17 01:32:27 PM
#29486   Anything is possible. If it does I will Dreamchaser007 08/19/17 09:03:15 PM
#29485   What will happen with the SP when Rexista declaes 08/19/17 07:15:22 AM
#29484   In the aggregate that means that about 10 AngeloFoca 08/18/17 02:55:58 PM
#29483   I fully agree with you fred - although AngeloFoca 08/18/17 02:37:12 PM
#29482   Yes, definitely not unheard of that the FDA fmgrana 08/18/17 01:25:30 PM
#29481   It is possible that Rexista would be tentatively fred198484 08/18/17 01:16:15 PM
#29480   They need cash and if they don't get fred198484 08/18/17 01:02:26 PM
#29479   Everyone... Just be clear on one thing... Rexista wimuskyfisherman 08/18/17 10:15:59 AM
#29478   Canada is contemplating making ALL opiods ADF. NASDAQ2020 08/18/17 10:15:14 AM
#29477   A clarification on First Foundation Advisors holdings fabius 08/18/17 10:09:10 AM
#29476   Tek, I agree that based on current share fabius 08/18/17 08:34:55 AM
#29475   I feel that at this point I would E Star Capital 08/18/17 12:10:46 AM
#29474   I remember hearing about the successful phase one E Star Capital 08/18/17 12:08:56 AM
#29473   I'm not worried about focilian and seroquel.. The mopar44o 08/17/17 07:29:21 PM
#29472   Time to assess the situation again. Looks Tekterra 08/17/17 05:47:32 PM
#29471   fred.............<<he obvious nasty thing which could happen would wimike 08/17/17 05:25:22 PM
#29470   The key one is whether or not the fred198484 08/17/17 05:05:43 PM
#29469   Thanks rayank 08/17/17 05:05:37 PM
#29468   Well any number of the ANDA's. 2 of mopar44o 08/17/17 05:04:49 PM
#29467   Any upcoming catalysts? Might get back in? rayank 08/17/17 04:42:58 PM
#29466   Who put in the market Order for approximately wimike 08/17/17 04:39:14 PM
#29465   Yep the buyout rumors continue. End of August wimuskyfisherman 08/17/17 04:36:57 PM
#29464   Lol gee where did I hear that before. mopar44o 08/17/17 04:16:06 PM
#29463   Doog- You guys need to drop off a wimuskyfisherman 08/17/17 03:27:14 PM
#29462   Della Penna's still there until months end...and I doogdilinger 08/17/17 09:18:17 AM
#29461   It's been a devastating butt kicking since adcom...but doogdilinger 08/17/17 09:17:18 AM
#29460   Yes maybe the 3 of us should meet doogdilinger 08/17/17 09:15:49 AM
#29459   mopar...... Riders on the storm by the Doors. wimike 08/16/17 05:33:33 PM
#29458   I plan to ride the storm out too. mopar44o 08/16/17 04:11:00 PM
#29457   doog....there is no one left to communicate. wimike 08/16/17 03:44:15 PM
#29456   Like I just said mopar...I'm not gonna argue doogdilinger 08/16/17 03:25:11 PM
#29455   You remember the Ranexa PR? mopar44o 08/16/17 03:22:21 PM
#29454   IPCI can't sit on material news...and an institution doogdilinger 08/16/17 02:53:27 PM
#29453   Maybe one billion by the time their done. mopar44o 08/16/17 02:46:59 PM
#29452   Suckers worth several billion dollars;) doogdilinger 08/16/17 02:42:07 PM
#29451   The could be suckers like us :P I mopar44o 08/16/17 02:40:20 PM
#29450   If that's the case then they would most doogdilinger 08/16/17 01:52:53 PM
#29449   mopar....yes I agree the silence is killing the wimike 08/16/17 01:34:19 PM
#29448   If that was the case I would ask mopar44o 08/16/17 01:02:04 PM
#29447   Yes if they continue accumulating then I'd say doogdilinger 08/16/17 11:55:37 AM
#29446   Doog, hope to see First Financial Advisors reaching fabius 08/16/17 11:51:21 AM
#29445   Yep because Dr. Odidi has been so against doogdilinger 08/16/17 11:50:34 AM
#29444   Well said and agreed fabius...they've clearly never really doogdilinger 08/16/17 11:45:22 AM
#29443   This latest blatant pump by that same group doogdilinger 08/16/17 11:41:46 AM
#29442   Let's just say that First Financial Advisors definitely doogdilinger 08/16/17 11:36:33 AM
#29441   Possible Doog, company may engage in third party Tekterra 08/16/17 11:14:00 AM
#29440   Fabius, it's not seams like, it is. Tekterra 08/16/17 11:03:18 AM
PostSubject