New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
December 2, 2013
07:05 EDTBDSIBioDelivery Sciences announces positive meeting with FDA for clonidine gel
BioDelivery Sciences announced that it engaged in a positive meeting with the FDA regarding the clinical development program for Clonidine Topical Gel that will allow the program to proceed to Phase 3 clinical studies in the first quarter of 2014. The FDA agreed with the overall clinical program proposed by BDSI which included two placebo-controlled studies and one safety study in patients suffering from painful diabetic neuropathy, the duration of treatment required for the safety assessment, and the plan for data integration from prior and planned clinical studies. The feedback from FDA enables BDSI to initiate the first of two placebo controlled studies in early 2014. If the initial placebo controlled study meets its primary endpoint, the results for which could be available as early as the end of 2014, BDSI could be in a position to initiate the second placebo controlled study in 2015 with an NDA projected for 2016.
News For BDSI From The Last 14 Days
Check below for free stories on BDSI the last two weeks.
Sign up for a free trial to see the rest of the stories you've been missing.
April 3, 2014
07:06 EDTBDSIBioDelivery Sciences begins enrollment in Phase 3 Clonidinie Topical Gel study
Subscribe for More Information

Sign up for a free trial to see the rest of the stories you've been missing.

I agree to the theflyonthewall.com disclaimer & terms of use