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Intellipharmaceutics International Inc. (IPCI)

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Last Post: 4/27/2017 8:35:34 PM - Followers: 220 - Board type: Free - Posts Today: 0




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) 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
PostSubject
#19060  Sticky Note Intellipharmaceutics Signs an Exclusive License and Commercial NASDAQ2020 10/11/16 08:22:05 PM
#26496   If so, it is a weak case against zoomlik 04/27/17 08:35:34 PM
#26495   Zoo....I have said previously it would not surprise Samsa 04/27/17 08:07:25 PM
#26494   Rumor has it that if I eat a Noodle2 04/27/17 04:53:07 PM
#26493   Price action before and after the Oct, 11, Noodle2 04/27/17 04:47:45 PM
#26492   Isn't it about time for a good rumor :-) wimuskyfisherman 04/27/17 04:46:53 PM
#26491   Lol, noticing the volumes were much higher the Tekterra 04/27/17 04:14:37 PM
#26490   Perhaps, this change was for their benefit? I'm Noodle2 04/27/17 04:12:22 PM
#26489   I hope someone does not come around and Noodle2 04/27/17 03:59:02 PM
#26488   Nice indeed. Let's hope this time it continues Noodle2 04/27/17 03:39:21 PM
#26487   Some nice buys coming in this afternoon!!!! mayvid 04/27/17 03:36:19 PM
#26486   LMAO Their lack of coverage doesn't mean a beachguy3363 04/27/17 01:04:20 PM
#26485   Children fighting Rexista depends on strength of lawsuit. zoomlik 04/27/17 12:45:17 PM
#26484   I believe a strong case can be made wimuskyfisherman 04/27/17 12:43:18 PM
#26483   wimusky, Amigo- I looked back at some of your Amigo Mike 04/27/17 12:36:42 PM
#26482   littleguy- that is a very interesting statistic. wimuskyfisherman 04/27/17 12:28:00 PM
#26481   Thanks Tek wimuskyfisherman 04/27/17 12:27:13 PM
#26480   Wimusky, in the article it said he had Tekterra 04/27/17 12:24:42 PM
#26479   Agreed Doog, wimuskyfisherman 04/27/17 12:06:03 PM
#26478   AstraZeneca US product sales decreased 34% q1 impacted littleguy25 04/27/17 11:52:54 AM
#26477   Sprot- As I said they had an $8 wimuskyfisherman 04/27/17 11:52:09 AM
#26476   Sprot, the 2$ target is just a way Tekterra 04/27/17 11:47:58 AM
#26474   If they stop covering, they know there isn't sprot 04/27/17 11:25:36 AM
#26473   Cysonic- It is better for IPCI to not wimuskyfisherman 04/27/17 11:22:52 AM
#26472   Aegis had a target of $8.00 for IPCI cysonic 04/27/17 11:13:41 AM
#26471   Aegis drops coverage of IPCI. wimuskyfisherman 04/27/17 11:08:41 AM
#26470   Doog, Tekterra 04/27/17 10:26:46 AM
#26469   I believe he was being facetious. Or perhaps E Star Capital 04/27/17 10:09:43 AM
#26468   Yay my IPCI is back over $2.00! smitter 04/27/17 10:08:52 AM
#26466   fmgrana. Really 400 shares in after hours at 92662 04/27/17 07:17:21 AM
#26465   NPODDS & PODRAS are both proprietary differentiators for doogdilinger 04/27/17 06:11:51 AM
#26464   Tekterra, Your comments are spot on. Personally tired Amigo Mike 04/27/17 12:09:42 AM
#26463   Eye Popping AH @ $2.07...:) fmgrana 04/26/17 06:39:05 PM
#26461   Purdue sued Collegium on patent 9,522,919 on April_21,2017. numbersarefun 04/26/17 05:21:02 PM
#26460   You bet Doog, freaking predictable here it's not funny. Tekterra 04/26/17 04:37:59 PM
#26459   Fred...I was giving him the answer of what Samsa 04/26/17 04:36:51 PM
#26458   Wimusky, that is correct they will have cash Tekterra 04/26/17 04:36:40 PM
#26457   Looks like our manipulative group of friends have doogdilinger 04/26/17 04:26:00 PM
#26456   Tek- Just one more thing. I personally believe wimuskyfisherman 04/26/17 04:23:31 PM
#26455   do you have a link to that? fred198484 04/26/17 04:04:30 PM
#26454   Tek- But the cash problem could be solved wimuskyfisherman 04/26/17 04:02:01 PM
#26453   Only if the Odidi's are interested in selling. fred198484 04/26/17 04:00:42 PM
#26452   We have been in circles on these discussions Tekterra 04/26/17 03:50:37 PM
#26451   Spot on and 100% agreed Angelo...the risks are doogdilinger 04/26/17 12:27:14 PM
#26450   All big pharmas started the same way little doogdilinger 04/26/17 12:24:51 PM
#26449   PODRAS actually makes it a much more complex AngeloFoca 04/26/17 12:20:39 PM
#26448   Me as well...I've always envisioned and expected IPCI doogdilinger 04/26/17 12:20:26 PM
#26447   wimusky....seems like the big pharmas get their drugs wimike 04/26/17 12:15:10 PM
#26446   Angelo- I agree, I am not selling for wimuskyfisherman 04/26/17 12:12:07 PM
#26444   If they make an offer for e.g. $200 AngeloFoca 04/26/17 12:09:39 PM
#26443   fabius...yes I agree. But that take away of wimike 04/26/17 12:08:56 PM
PostSubject