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Intellipharmaceutics International Inc. (IPCI)

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Last Post: 5/30/2017 7:36:14 AM - Followers: 221 - Board type: Free - Posts Today: 1

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: Securities Registration (foreign Private Issuer) (f-3/a) 06:05 AM
IPCI News: Report of Foreign Issuer (6-k) 06:05 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
IPCI News: Securities Registration (foreign Private Issuer) (f-3) 05/26/2017 04:50:27 PM
IPCI News: Report of Foreign Issuer (6-k) 05/24/2017 04:16:21 PM
News News Alert: Securities Registration (foreign Private Issuer) (f-3/a) 05/30/2017 06:05:31 AM
#19060  Sticky Note Intellipharmaceutics Signs an Exclusive License and Commercial NASDAQ2020 10/11/16 08:22:05 PM
#27443   With the aim of replacing its expiring shelf declaes 05/30/17 07:36:13 AM
#27442   Weezuhl, Bottom line, Amigo Mike 05/29/17 08:13:44 PM
#27440   Finally. Someone gets it. WeeZuhl 05/29/17 11:37:34 AM
#27439   WeeZuhl, your whole reasoning is irrelevant as you WeeZuhl 05/29/17 10:43:51 AM
#27434   WeeZuhl, your whole reasoning is irrelevant as you cysonic 05/29/17 03:13:01 AM
#27432   Samsa, thanks for your response WeeZuhl 05/29/17 12:19:17 AM
#27431   Very, very WRONG. WeeZuhl 05/28/17 09:59:26 PM
#27430   hi Doog and when Mallinkrodt launched Seroquel XR declaes 05/28/17 04:46:17 PM
#27429   In the new filing the company says there wimike 05/28/17 03:39:28 PM
#27428   I agree. It essentially ensures CFP by 3rd q mopar44o 05/28/17 11:01:04 AM
#27427   Look at the OBV - accumulation, accumulation, accumulation!! scapaflow 05/28/17 09:20:16 AM
#27425   To me the interesting part is only SOME zoomlik 05/27/17 04:32:21 PM
#27424   i dont beleave in massiv upcoming dilution xr_biotech_consult 05/27/17 04:19:44 PM
#27423   Pursuant to Rule 415(a)(6) under the Securities Act, xr_biotech_consult 05/27/17 04:16:16 PM
#27422   Pursuant to the Dawson James Underwriting Agreement, in AngeloFoca 05/27/17 02:41:56 PM
#27421   So we're on track and will NOT need AngeloFoca 05/27/17 02:41:15 PM
#27420   Will FDA data of sept 2017 for Rexista zoomlik 05/27/17 09:46:25 AM
#27419   Excellent due diligence as always cysonic! Enough cash doogdilinger 05/27/17 09:29:03 AM
#27418   fmgrana, don't overlook this key part of cysonic's due>>> doogdilinger 05/27/17 09:26:20 AM
#27417   Cysonic, September 2017 promises to be a significant fmgrana 05/27/17 08:58:44 AM
#27416   Cysonic....I agree, there should not be a need Samsa 05/27/17 07:38:32 AM
#27415   Read the prospectus - great news here: cysonic 05/27/17 04:18:34 AM
#27414   BIM will buy further, boatloads, when/if the price kfcyahoo 05/26/17 07:36:05 PM
#27412   Angelo....agreed! Clearly it is being ignored Samsa 05/26/17 06:49:45 PM
#27411   IPCI files for a new shelf to replace Samsa 05/26/17 06:46:48 PM
#27410   IPCI may offer and issue from time to xr_biotech_consult 05/26/17 05:29:35 PM
#27409   Agree. His(her?) argument is that IPCI's Rexista w kfcyahoo 05/26/17 05:29:17 PM
#27408   Can we stop with the blue dye crap AngeloFoca 05/26/17 03:37:14 PM
#27407   mopar44o   doogdilinger 05/26/17 03:04:55 PM
#27406   Thanks for the response on the blue dye wimuskyfisherman 05/26/17 02:57:15 PM
#27405   correction,.1mg/kg=.0454mg/lb kfcyahoo 05/26/17 02:21:42 PM
#27404   I couldn't find the amount, but the second littleguy25 05/26/17 02:18:50 PM
#27403   I found this on wiki: kfcyahoo 05/26/17 02:18:05 PM
#27402   Samsa- Exactly my sentiments too! wimuskyfisherman 05/26/17 02:17:54 PM
#27401   Does anyone know what the maximum levels the wimuskyfisherman 05/26/17 02:02:38 PM
#27400 the counter claim they are going after Samsa 05/26/17 01:52:16 PM
#27399   I have already posted why your argument is Samsa 05/26/17 01:37:08 PM
#27398   Purdue vs IPCI.........If IPCI wants to settle this wimike 05/26/17 12:58:56 PM
#27397   I came here to get my laugh for wimuskyfisherman 05/26/17 11:24:13 AM
#27390   Oh yessssssss WeeZuhl...FDA approved blue dye # 1 doogdilinger 05/26/17 08:49:36 AM
#27389   The panel committee is going to get a WeeZuhl 05/26/17 08:42:00 AM
#27388   Excellent mopar44...the back half of this year is doogdilinger 05/26/17 08:39:53 AM
#27386   I know that Purdue used a switched venues doogdilinger 05/26/17 08:36:23 AM
#27385   Thanks for staying on top of things for doogdilinger 05/26/17 08:34:42 AM
#27383   lmfao touche WeeZuhl...hilarious that the only evidence you doogdilinger 05/26/17 08:29:19 AM
#27382   lmfao more faulty manufactured blue dye tinted feeding WeeZuhl 05/26/17 08:26:03 AM
#27381   Thx Samsa. Will the one attorney not with kfcyahoo 05/26/17 08:19:37 AM
#27380   lmfao more faulty manufactured blue dye tinted feeding doogdilinger 05/26/17 08:14:49 AM
#27379   KFC.....He is actually a partner with the same Samsa 05/26/17 07:39:44 AM
#27376   citing 1 single isolated case of faulty manufactured WeeZuhl 05/26/17 01:35:45 AM