IPCI has a very large and attractive Product Pipel
Post# of 30
Posted On: 06/02/2016 10:32:56 AM
IPCI has a very large and attractive Product Pipeline with 8 Drugs awaiting FDA approval which could they could approved anytime now . Their Key Drug is Rexista a potential Best in Class Abuse Deterrent Pain Drug with HUGE Market Potential . NDA Filing for the Drug is planned within Weeks (June or July) .We could see $5++ easily with NDA filing and Runup to FDA decision (4Q16 or early 1Q2017) and much higher if there is any approval of the Drugs under review by FDA . This ultra Low float Stock is a lifetime opportunity here close at ATL . GL
Intellipharmaceutics (Nasdaq: IPCI)
Market Cap: $44 Million
Cash: $6 Million
Price: $1.59
Shares Out: 28 Million
Slide Presentation
http://files.shareholder.com/downloads/ABEA-4...ersion.pdf
Intellipharmaceutics(IPCI-NASDAQ, Speculative Buy, US$12 target)
Intellipharmaceutics International Inc.: Investors should focus on Rexista Oxycodone XR (pain) targeting a US$2.3 billion market. On May 21, FDA gave guidance to IPCI that the Rexista NDAcould be filed without a Phase 3 trial if they could demonstrate bioequivalence to Oxycontin. By IPCI only having to do a bioequivalence trial for Rexista Oxycodone XR, compared to Purdue’s Oxycontin, the company will now run a smaller trial of only 24-40 patients. IPCI should be able to file for FDA approval in H1 2016.
There are several catalysts for IPCI expected: (i) clinical results for the Rexista oxycodone pharmacokinetic studies (fed and fasting) likely in November 2015 (ii) an NDA filing for Rexista Oxycodone in H1 2015 (iii) 7 ANDA approvals could come at any point as the generic arm of the FDA clears its backlog and (iv) management has been actively working on licensing its products (generics and brand) such a transaction could be forged in H1 2016. On May 26, FDA granted Rexista Oxycodone XR fast track designation. With a “fast track designation” for Rexista Oxycodone XR, it is possible the NDA could be reviewed in 6 months or less and the drug could be launched at the end of 2016/H1 2017 (we have modeled in a mid 2017 to H2 2017 launch which is now very conservative).
Intellipharmaceutics (Nasdaq: IPCI)
Market Cap: $44 Million
Cash: $6 Million
Price: $1.59
Shares Out: 28 Million
Slide Presentation
http://files.shareholder.com/downloads/ABEA-4...ersion.pdf
Intellipharmaceutics(IPCI-NASDAQ, Speculative Buy, US$12 target)
Intellipharmaceutics International Inc.: Investors should focus on Rexista Oxycodone XR (pain) targeting a US$2.3 billion market. On May 21, FDA gave guidance to IPCI that the Rexista NDAcould be filed without a Phase 3 trial if they could demonstrate bioequivalence to Oxycontin. By IPCI only having to do a bioequivalence trial for Rexista Oxycodone XR, compared to Purdue’s Oxycontin, the company will now run a smaller trial of only 24-40 patients. IPCI should be able to file for FDA approval in H1 2016.
There are several catalysts for IPCI expected: (i) clinical results for the Rexista oxycodone pharmacokinetic studies (fed and fasting) likely in November 2015 (ii) an NDA filing for Rexista Oxycodone in H1 2015 (iii) 7 ANDA approvals could come at any point as the generic arm of the FDA clears its backlog and (iv) management has been actively working on licensing its products (generics and brand) such a transaction could be forged in H1 2016. On May 26, FDA granted Rexista Oxycodone XR fast track designation. With a “fast track designation” for Rexista Oxycodone XR, it is possible the NDA could be reviewed in 6 months or less and the drug could be launched at the end of 2016/H1 2017 (we have modeled in a mid 2017 to H2 2017 launch which is now very conservative).
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