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Intellipharmaceutics International Inc. (IPCI)

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Last Post: 9/25/2017 11:10:14 AM - Followers: 226 - Board type: Free - Posts Today: 36




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) 07:12 AM
IPCI News: Intellipharmaceutics Receives Complete Response Letter from the FDA for Rexista™ NDA 07:00 AM
IPCI News: Report of Foreign Issuer (6-k) 09/20/2017 05:18:47 PM
IPCI News: Intellipharmaceutics Announces Receipt of Nasdaq Notice 09/20/2017 05:10:00 PM
IPCI News: Report of Foreign Issuer (6-k) 09/05/2017 02:43:50 PM
News News Alert: Report of Foreign Issuer (6-k) 09/25/2017 07:12:00 AM
PostSubject
#29869  Sticky Note Great job Doog! Other shareholders please call Abby wimuskyfisherman 09/20/17 03:43:56 PM
#19060  Sticky Note Intellipharmaceutics Signs an Exclusive License and Commercial NASDAQ2020 10/11/16 08:22:05 PM
#30046   Maxim is out with a report that says fred198484 09/25/17 11:10:14 AM
#30045   Fabius- My guess at this point is they wimuskyfisherman 09/25/17 10:49:18 AM
#30044   lol LexTrader 09/25/17 10:48:13 AM
#30043   We're so sorry Uncle Albert. NO WE'RE NOT! AngeloFoca 09/25/17 10:47:29 AM
#30042   A couple things: wimuskyfisherman 09/25/17 10:35:53 AM
#30041   Fred, Company indicated 9months for the studies in fabius 09/25/17 10:25:30 AM
#30040   Shorts covering??? $1.09 now... fmgrana 09/25/17 10:23:47 AM
#30039   OK - so Rexista is not dead and fred198484 09/25/17 10:03:23 AM
#30038   We're so sorry Uncle Albert. LexTrader 09/25/17 10:02:55 AM
#30037   it says zero to borrow w 99% interest microcaptrdr24 09/25/17 09:58:32 AM
#30036   Anyone with Fidelety brokerage here that knows or AngeloFoca 09/25/17 09:45:48 AM
#30035   Double bottom if this breaks it could get ugly. tilator 09/25/17 09:16:35 AM
#30034   Double bottom if this breaks it could get ugly. mentalist 09/25/17 09:07:47 AM
#30033   " and we do not expect they will fabius 09/25/17 08:36:44 AM
#30032   When will they report next earning? tilator 09/25/17 08:30:09 AM
#30030   has to be out by 10/15 but I microcaptrdr24 09/25/17 08:28:54 AM
#30029   When will they report next earning? Hebrew 09/25/17 08:27:07 AM
#30028   agree, earnings will take this back up quickly microcaptrdr24 09/25/17 08:24:46 AM
#30025   Exactly doog... this manipulation of the ppi will beachguy3363 09/25/17 07:49:18 AM
#30024   Weird there is no premarket activity. Also the Hebrew 09/25/17 07:48:29 AM
#30023   Agreed beachguy...nice to see this line included in doogdilinger 09/25/17 07:42:47 AM
#30022   Agreed fred, interesting about the FDA's request for doogdilinger 09/25/17 07:40:52 AM
#30021   Rexista's on track to be approved sometime next doogdilinger 09/25/17 07:39:16 AM
#30019   Why would you presume I am short ? mentalist 09/25/17 07:27:16 AM
#30018   LMAO... better cover your short position before they beachguy3363 09/25/17 07:24:21 AM
#30015   FDA Asking for Cat 2 and Cat 3 mentalist 09/25/17 07:08:31 AM
#30014   mentalist 09/25/17 07:07:52 AM
#30013   Intellipharmaceutics Receives Complete Response Letter from the FDA mopar44o 09/25/17 07:04:12 AM
#30012   As we thought - there is a future fred198484 09/25/17 07:03:46 AM
#30011   great post DD , and as always , purefreewater 09/25/17 01:06:17 AM
#30010   I believe you have it about right. This fred198484 09/24/17 12:50:18 PM
#30009   The talk about buyout and partnership is ridiculous. wimuskyfisherman 09/24/17 12:10:43 PM
#30008   Most companies would want to announce bad news AngelofDeath1 09/24/17 06:40:19 AM
#30007   The F D A notifies the company of AngelofDeath1 09/24/17 06:37:25 AM
#30006   I want to believe that if it was tilator 09/24/17 04:51:30 AM
#30005   Not if the stock is not trading. aftermarket fred198484 09/23/17 09:27:00 PM
#30004   I want to believe that if it was mopar44o 09/23/17 09:10:00 PM
#30003   No, they almost certainly have been told what fred198484 09/23/17 09:04:04 PM
#30002   Would they halt it preemptively without news? mopar44o 09/23/17 08:06:46 PM
#30001   Never believed that you had, not for a fmgrana 09/23/17 06:37:30 PM
#30000   Yep it's clearly in regards to Mondays Rexista doogdilinger 09/23/17 10:00:34 AM
#29999   I have not gone to the dark side. doogdilinger 09/23/17 09:58:52 AM
#29998   Material... could just be FDA decision? fabius 09/23/17 05:28:37 AM
#29997   Material... could just be FDA decision? fabius 09/23/17 05:28:18 AM
#29996   T1 = material news pending tilator 09/23/17 04:06:15 AM
#29995   Odd, agreed. Maybe the received FDA decision and fabius 09/23/17 02:58:24 AM
#29994   I mentioned earlier it is normal for the fred198484 09/22/17 10:46:59 PM
#29993   Yup LexTrader 09/22/17 08:49:37 PM
#29992   T1 halt... jobynimble 09/22/17 08:46:51 PM
#29991   This halt ain't your typical AH Friday halt. LexTrader 09/22/17 07:51:51 PM
PostSubject