Intellipharmaceutics International Inc. (IPCI)

[Bernstein]

SUPER CHEAP ..NDA resubmission for Oxycodone ER expected by year end so FDA decision will be around May or June ( Class 2 Resubmission 6-month review cycle) . With the cash on hand and the NDA resubmission in near term this stock is very attractive at this price i think $3-4 before FDA decision is likely .


The abuse liability studies for the intranasal route of abuse commenced in May 2018 with subject screening, while the studies to support abuse-deterrent label claims for the oral route of abuse commenced in June 2018. The clinical part of both studies has now been completed. Bioanalytical samples and statistical analysis for such studies are pending. An update on the results will be provided once the analysis is complete.

The FDA granted our request for an extension to February 28, 2019 to resubmit our NDA for Oxycodone ER under section 505(b)(2) of the U.S. Federal Food, Drug and Cosmetic Act. However, we plan to resubmit the application later this year.