The new indication of PROC and 505(b)(2) pathway was hardest to...

The new indication of PROC and 505(b)(2) pathway was hardest to get through with FDA

A pleasant surprise considering Irinotecan has not been approved as an indication for Platinum Resistant Ovarian Cancer

There are three other indications that are being addressed with DEP® Cabazitaxel and DEP® SN38 and all 3 should be a formality to be fast tracked using 505(b)(2) pathway considering the drugs Cabazitaxel and Irinotecan already use these indications to address the particular cancers

Note in Starpharma announcement and I quote

“Starpharma’s meeting with the FDA provided clear guidance on the most efficient path forward for the development and eventual registration of DEP® SN38 as a promising new treatment for patients with platinum-resistant ovarian cancer. This disease represents a significant unmet medical need, and the FDA demonstrated a clear, positive intention to work constructively with the company on the DEP® SN38 program, with the goal of bringing a much-needed new therapy to patients with platinum-resistant ovarian cancer as rapidly as possible.”



The penny has not dropped yet