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Intellipharmaceutics International Inc. (IPCI)

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Last Post: 6/25/2017 4:01:37 PM - Followers: 224 - Board type: Free - Posts Today: 3




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: Report of Foreign Issuer (6-k) 06/06/2017 08:55:37 AM
IPCI News: Intellipharmaceutics Announces Launch of Generic Seroquel XR® by Mallinckrodt 06/06/2017 08:50:00 AM
IPCI News: Securities Registration (foreign Private Issuer) (f-3/a) 05/30/2017 06:05:31 AM
IPCI News: Report of Foreign Issuer (6-k) 05/30/2017 06:05:30 AM
IPCI News: Intellipharmaceutics Files Preliminary Base Shelf Prospectus and Shelf Registration Statement to Replace Expiring Shelf Regis... 05/26/2017 05:40:00 PM
PostSubject
#19060  Sticky Note Intellipharmaceutics Signs an Exclusive License and Commercial NASDAQ2020 10/11/16 08:22:05 PM
#27874   Nice thanks! StickyStock 06/25/17 04:01:37 PM
#27873   Intellipharmaceutics Announces FDA Approval for 500 mg and xr_biotech_consult 06/25/17 03:36:45 PM
#27872   When was Gluco approved? http://www.intellipharmaceutics.com/pipeline.cfm StickyStock 06/25/17 01:55:07 PM
#27871   Yeah I'm still kind of surprised gluco isn't mopar44o 06/24/17 07:55:44 PM
#27870   Wim...while we wait on those 3QE numbers I Samsa 06/23/17 04:05:24 PM
#27869   doogdilinger, final 2 doses offset by exclusivity ending. numbersarefun 06/23/17 03:21:55 PM
#27868   Been a lurker for many years and am me5519 06/23/17 02:13:46 PM
#27867   We've finally started to see signs from IPCI doogdilinger 06/23/17 01:05:39 PM
#27866   Actual Q2 numbers are not important. What management fred198484 06/23/17 12:48:36 PM
#27865   I am hoping PAR launches the last two doogdilinger 06/23/17 12:18:45 PM
#27864   Everyone- Q2 numbers will be out soon... Continued wimuskyfisherman 06/23/17 11:40:54 AM
#27863   Face it, did you ever wonder how the doogdilinger 06/23/17 10:34:32 AM
#27862   LOL.....it is going to be a Lawyers dream! Samsa 06/22/17 06:39:46 PM
#27861   Interesting coverage just now on CNBC and State fmgrana 06/22/17 02:17:26 PM
#27860   How many Abuse Deterrent patents are there in NASDAQ2020 06/21/17 10:20:29 PM
#27859   so just noticed this on the top of Samsa 06/21/17 10:08:09 AM
#27858   Hebrew....nothing much. they had to reschedule the Samsa 06/21/17 10:01:42 AM
#27857   Agreed wimusky, IPCI's Rexista is the 1st to doogdilinger 06/21/17 08:37:29 AM
#27856   Agreed mopar, stage is set for a stellar doogdilinger 06/21/17 08:35:12 AM
#27855   Looks like ipci's patience is going to pay mopar44o 06/21/17 07:41:44 AM
#27854   Samsa, anything new about the lawsuit? Hebrew 06/21/17 05:42:13 AM
#27853   Yes sir. LexTrader 06/20/17 03:14:09 PM
#27852   Lex- I think this gives IPCI a distinct wimuskyfisherman 06/20/17 03:12:59 PM
#27851   Yes, this prunes out the competition. LexTrader 06/20/17 01:38:39 PM
#27850   Lex- This is not the first time that wimuskyfisherman 06/20/17 12:06:43 PM
#27849   also, COLL up another 7% on EGLT's misfortune....recall, cdnrx 06/20/17 10:10:02 AM
#27848   Wow. It seems FDA is looking at these cdnrx 06/20/17 09:45:11 AM
#27847   Competitor news:EGLT The FDA has requested more information LexTrader 06/20/17 09:18:16 AM
#27846   Yes I noticed. Smaller buy took it up. wimuskyfisherman 06/19/17 10:40:27 AM
#27845   Did you notice: 2 relatively large block orders cysonic 06/19/17 10:30:51 AM
#27844   It's been 7/8 months since IPCI last traded doogdilinger 06/19/17 09:49:19 AM
#27843   Hebrew.....Yes.....The 30 month stay in effect, only affects Samsa 06/18/17 08:18:39 PM
#27842   Legal question: Can the FDA hold an Adcom Hebrew 06/18/17 09:13:21 AM
#27841   Agreed wimusky the opioid addiction epidemic/crisis centers around doogdilinger 06/18/17 09:00:33 AM
#27840   Angelo - come on... Anybody that doesn't know wimuskyfisherman 06/17/17 02:19:07 PM
#27839   Intellipharmaceutics Augments Its Rexista(TM) Oxycodone Development Program With Investor100 06/17/17 01:49:58 PM
#27838   all the addicts I know do not take AngeloFoca 06/17/17 01:46:59 PM
#27837   Amigo mike- all the addicts I know do wimuskyfisherman 06/17/17 11:29:32 AM
#27836   Makes IPCI that much more valuable. IMO LexTrader 06/17/17 11:24:05 AM
#27835   Cysonic. You post the news about the new lawsuits Amigo Mike 06/17/17 10:35:09 AM
#27834   Cysonic - I agree if podras can be wimuskyfisherman 06/17/17 09:43:16 AM
#27833   New lawsuits against Purdue Pharma, Mallinckrodt and Endo Pharmaceuticals: cysonic 06/17/17 09:19:16 AM
#27832   bid at 2.10 for 62.4K shares... is sprot AngeloFoca 06/16/17 03:18:20 PM
#27831   Link to White House opioid panel meeting. Starts littleguy25 06/16/17 12:26:08 PM
#27830   They might look at you as a pumper Tekterra 06/16/17 11:15:55 AM
#27829   We can help get the word out on doogdilinger 06/16/17 08:17:26 AM
#27828   Back half of 2017's set up to become doogdilinger 06/16/17 08:06:36 AM
#27827   IPCI @ Stockcharts Investor100 06/15/17 08:34:49 PM
#27826   Agree Tekterra. Positive coverage by another Investment Seventh 06/15/17 02:14:37 PM
#27825   Tekterra....That is what actually frustrated me about the Samsa 06/15/17 02:12:18 PM
PostSubject