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Intellipharmaceutics International Inc. (IPCI)

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Last Post: 10/25/2016 2:53:50 PM - Followers: 204 - Board type: Free - Posts Today: 28

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:
                                                                Pipeline Chart

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) 10/14/2016 09:04:57 AM
IPCI News: Intellipharmaceutics to Present at Dawson James Securities Growth Stock Conference 10/14/2016 09:00:00 AM
IPCI News: Report of Foreign Issuer (6-k) 10/14/2016 06:07:50 AM
IPCI News: Intellipharmaceutics Announces Third Quarter 2016 Results 10/13/2016 11:00:00 PM
IPCI News: Report of Foreign Issuer (6-k) 10/11/2016 05:08:18 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
#19777   Does the 3 million dollar upfront payment IPCI need2berich 10/25/16 02:53:50 PM
#19776   Hmm Noodle2 10/25/16 02:06:41 PM
#19775   The next 6 months are going to be doogdilinger 10/25/16 01:24:26 PM
#19774   Nice! It's definitely going to be a blockbuster:) doogdilinger 10/25/16 01:23:43 PM
#19773   Go IPCI!!! Noodle2 10/25/16 01:17:56 PM
#19772   I just Googled "Regabatin Ihub" and some old posts. Noodle2 10/25/16 01:17:50 PM
#19771   From that same thread Noodle>>> doogdilinger 10/25/16 01:12:28 PM
#19770   Nice find thnx Noodle:) doogdilinger 10/25/16 01:08:47 PM
#19769   Hope this helps, Doog. Noodle2 10/25/16 01:07:30 PM
#19768   excellent insight , thank you Doog ! purefreewater 10/25/16 01:05:05 PM
#19767   What's with the low volume today? Sparky77 10/25/16 12:49:25 PM
#19766   Agreed bro...there used to be a poster here doogdilinger 10/25/16 12:45:36 PM
#19765   absolutely, because every presentation they have made includes Samsa 10/25/16 12:21:54 PM
#19764 Noodle2 10/25/16 12:12:52 PM
#19763   Agreed Samsa, I probably shouldn't have left Regabatin doogdilinger 10/25/16 11:41:42 AM
#19762 missed a big one ! Samsa 10/25/16 11:40:04 AM
#19761   Agreed fabius and no matter what, with over doogdilinger 10/25/16 11:14:47 AM
#19760   Doog, would be nice to receive one approval fabius 10/25/16 11:10:19 AM
#19759   IPCI pending catalysts doogdilinger 10/25/16 11:09:05 AM
#19758   Glucophage, Effexor & Protonix ANDA's all over +6 doogdilinger 10/25/16 11:00:29 AM
#19757   Hey great job on the IPCI product pipeline doogdilinger 10/25/16 10:11:14 AM
#19756   haha I like the way you're thinking Noodle...we doogdilinger 10/25/16 10:09:52 AM
#19755   PR today? Why not? It's a Tuesday. Noodle2 10/25/16 09:47:31 AM
#19754   Hmm Noodle2 10/25/16 09:38:44 AM
#19753   GM tjguy agreed. I'm just focused on the doogdilinger 10/25/16 09:14:23 AM
#19752   strongly agree with you Samsa, fabius 10/25/16 08:55:58 AM
#19751   tjguy.....dont get discouraged. I was taught you Samsa 10/25/16 08:14:42 AM
#19750   CEO Odidi himself is the one who claims tjguy 10/25/16 04:15:56 AM
#19749   CEO Odidi himself is the one who claims doogdilinger 10/24/16 11:47:11 PM
#19748   numbers.....actually, I wouldn't discount it too quickly that Samsa 10/24/16 06:59:34 PM
#19747   Biovail's fortune tied mostly to Wellbutrin XL. numbersarefun 10/24/16 05:39:05 PM
#19746   Exactly. Excellent Consolidation! and Base building around $3.00 smitter 10/24/16 04:41:18 PM
#19745   Imapct....Ive been a holder since mid 2012.....I agree Samsa 10/24/16 03:57:45 PM
#19744   Agreed creating and cultivating shareholder value has always doogdilinger 10/24/16 02:53:08 PM
#19743   Well summarized Impact! Bring on the next PODRAS doogdilinger 10/24/16 02:48:21 PM
#19742   Impact- I agree 100% with your statement that wimuskyfisherman 10/24/16 02:36:46 PM
#19741   HISTORY ImpactTrader16 10/24/16 02:00:12 PM
#19738   I wish they would buy it up faster Sparky77 10/24/16 01:18:44 PM
#19737   if you all look at the volume chart purefreewater 10/24/16 01:15:37 PM
#19736   At least 3.00 seems to be holding pretty Despicable_Z 10/24/16 12:49:01 PM
#19735   I have been in this stock for 4 oregon 1 10/24/16 11:35:28 AM
#19734   Agreed impact, one little tidbit of information and Sparky77 10/24/16 11:35:23 AM
#19733   Can you say SLING SHOT EFFECT :) ImpactTrader16 10/24/16 11:29:55 AM
#19732   Why Oregon, what has changed? Nothing new, No? sprot 10/24/16 11:29:00 AM
#19731   Back in the 2s unreal. oregon 1 10/24/16 11:26:54 AM
#19730   Absolutely, no doubt whatsoever that its shorts at ImpactTrader16 10/24/16 11:05:34 AM
#19729   ImpactTrader what does LvII look like? Is it Sparky77 10/24/16 10:43:19 AM
#19728   Ready for the bounce today. Wondering if we Despicable_Z 10/24/16 10:31:29 AM
#19727   I'am READY. oregon 1 10/24/16 10:12:46 AM
#19726   Congratz Oregon...bring on the next PODRAS and Rexista doogdilinger 10/24/16 10:12:06 AM