InvestorsHub Logo
Followers 56
Posts 6344
Boards Moderated 0
Alias Born 10/01/2012

Re: doogdilinger post# 7650

Friday, 06/06/2014 12:25:20 PM

Friday, June 06, 2014 12:25:20 PM

Post# of 38634

We plan to seek a Special Protocol Assessment (“SPA”) from the United States Food and Drug
Administration (“FDA”) to assist us in our plans to conduct a pivotal Phase III study in preparation for a
New Drug Application (“NDA”) 505(b)(2) application. The purpose of the SPA is to reach an agreement
with the FDA regarding the study design, endpoints and statistical analyses needed to support approval of
Rexista™ oxycodone prior to initiating the Phase III study. We will also be seeking a licensing partner for
the Phase III studies. Intellipharmaceutics’ previously announced development goals for 2013 included the
completion of Phase I studies of Rexista™ oxycodone. We currently expect to carry out additional Phase I
studies by the 4th quarter of 2013, and to initiate Phase III trials by the first half of 2014.



I found it so should happen by end of this month.............GLTA.