DEP Phase 3 trials no certainty, page-5

But @sarge17 we have been told constantly by JF and Starpharma ( and @antibotter) that we didn't need phase 3 trials .... we were a shoe in for the FDA Section 505 (b) [2] application for our DEP in house trialed drugs ..... supposedly so easy for any of the big pharmas to do and yet they're still not interested ? lol


Post #:66584800

As previously stated by Starpharma in announcements over the years, once phase 2 of the three in house trials have been completed and licensed out to a tier 1 pharma, a 505(b)(2) application may be made to the regulatory authorities to bypass phase 3 clinical trials and bring straight to market our Dep Docetaxel, Dep Cabazitaxel, and Dep Irinotecan


Post #:66588151

Based on the a 505(b)(2) application scenario being successful, tier 1 pharma would spend absolutely nothing on Phase 3 trials.