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Intellipharmaceutics International Inc. (IPCI)

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Last Post: 4/25/2017 2:35:34 PM - Followers: 221 - Board type: Free - Posts Today: 31

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 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
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

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) 04/19/2017 06:04:59 AM
IPCI News: Intellipharmaceutics Reports Director Election Results 04/18/2017 06:15:00 PM
IPCI News: Report of Foreign Issuer (6-k) 04/12/2017 06:05:09 AM
IPCI News: Intellipharmaceutics Announces First Quarter 2017 Results 04/11/2017 06:48:48 PM
IPCI News: Report of Foreign Issuer (6-k) 04/10/2017 08:04:54 AM
#19060  Sticky Note Intellipharmaceutics Signs an Exclusive License and Commercial NASDAQ2020 10/11/16 08:22:05 PM
#26394   IPCI isn't even registering a pulse with institutional doogdilinger 04/25/17 02:35:34 PM
#26393   lmao hilarious Angelo! doogdilinger 04/25/17 02:19:27 PM
#26392   Amen, Doog! Well stated. Can't wait fmgrana 04/25/17 01:59:16 PM
#26391   It's double edged sward Sam, the keyword here Tekterra 04/25/17 01:53:18 PM
#26390   Wouldn't that be nice ! ! ! AngeloFoca 04/25/17 01:39:43 PM
#26389   Don't forget the words: sprot 04/25/17 01:34:05 PM
#26388   Angelo- You yourself said PAR has about 34% AngeloFoca 04/25/17 01:27:14 PM
#26387   There's a reason institutional money is waiting to doogdilinger 04/25/17 01:03:39 PM
#26386   I added a few too cysonic...looking fwd to doogdilinger 04/25/17 12:58:34 PM
#26385   Tekterra....Im not saying any more than what the Samsa 04/25/17 12:43:16 PM
#26384   I added to my position and expect a cysonic 04/25/17 11:59:07 AM
#26380   Tek- The bad news that could happen would wimuskyfisherman 04/25/17 11:09:28 AM
#26379   Cysonic, I agree Sprot tends to be overly Tekterra 04/25/17 11:02:26 AM
#26377   Yeah, I keep saying people are waiting till Tekterra 04/25/17 10:47:21 AM
#26376   Not necessary, no news here is good enough sprot 04/25/17 10:44:06 AM
#26375   Thanx Tek, and respect!! sprot 04/25/17 10:38:53 AM
#26374   If it won't hold, that means bad news coming. Tekterra 04/25/17 10:31:38 AM
#26373   Sam, one thing I've noticed is that you Tekterra 04/25/17 10:30:06 AM
#26372   Tek, it won't hold sprot 04/25/17 10:27:59 AM
#26371   Sprot, this will go down lower if we Tekterra 04/25/17 10:20:52 AM
#26370   sprot 04/25/17 09:52:40 AM
#26369   I am still wondering how it can be WeeZuhl 04/25/17 08:03:50 AM
#26366   This morning I looked again at the pipeline Hebrew 04/25/17 04:14:21 AM
#26364   You won't see big volume as there will sprot 04/25/17 02:45:44 AM
#26363   wimike- Yes, we always see big volume at wimuskyfisherman 04/24/17 10:20:52 PM
#26362   Sport is probably right .. absent news, this zoomlik 04/24/17 09:28:41 PM
#26361   Tek....been my analysis that good news is preceded wimike 04/24/17 09:28:20 PM
#26360   sprot......not if we get good news. You will wimike 04/24/17 09:15:46 PM
#26359   Tekterra.....Oh don't worry I have been in this Samsa 04/24/17 06:28:49 PM
#26358   I think ask is going to move up Tekterra 04/24/17 05:55:29 PM
#26357   Makes sense .. So your thought is rev zoomlik 04/24/17 04:44:39 PM
#26356   By the end of the week we will sprot 04/24/17 04:17:51 PM
#26355   5 as far as I know doogdilinger 04/24/17 03:58:50 PM
#26354   Agreed numbers but IPCI/MNK and 4 others will doogdilinger 04/24/17 03:58:19 PM
#26353   Is there a way to find out how zoomlik 04/24/17 03:53:15 PM
#26352   FocalinXR is DEA_Schedule_II controlled drug, SeroquelXR is not. numbersarefun 04/24/17 03:34:40 PM
#26351   Sprot- I will agree with you on one wimuskyfisherman 04/24/17 03:30:04 PM
#26350   Angelo- You yourself said PAR has about 34% wimuskyfisherman 04/24/17 03:26:49 PM
#26349   We will see .. if you are around zoomlik 04/24/17 03:15:02 PM
#26348   Angelo- I use many factors to come up with wimuskyfisherman 04/24/17 02:38:27 PM
#26347   But my estimates for Seroquel are coming in AngeloFoca 04/24/17 02:35:03 PM
#26346   My numbers assumed double for margins .. yours AngeloFoca 04/24/17 01:26:11 PM
#26345   Hey Doog, mackie is forcasting a shareprice of sprot 04/24/17 12:40:39 PM
#26344   My numbers assumed double for margins .. yours zoomlik 04/24/17 12:39:25 PM
#26343   I'm looking for at least $1.5M per month doogdilinger 04/24/17 12:32:08 PM
#26342   Zoom- I am coming up with same as AngeloFoca 04/24/17 12:26:07 PM
#26341   I think your $3M is probably closer for zoomlik 04/24/17 12:24:34 PM
#26340   Fabius- Once IPCI starts showing a consistent profit. wimuskyfisherman 04/24/17 12:15:18 PM
#26339   Angelo- I hope you are right. But my wimuskyfisherman 04/24/17 12:05:23 PM
#26338   If overall 1- net margins is 3X 2- market zoomlik 04/24/17 12:01:10 PM