RE:RE:RE:RE:Investor Presentation [12-2024]It sure looks that way. Looking at the BTD process, after the first pre-BTD the FDA wanted Post Study II Monitoring Of Response and Central Pathology Lab Review and after the second pre-BTD the FDA asked for a different format to present the clinical data to better align with clinical data supplied by other companies. By "other companies" do they mean ones that have already been approved? Being this late in the process that's what I would think and that would have to be a positive.
Lesalpes29 wrote: BTD-Accelerared approval could be closer than we think. Problably why they are opening new sites. The only explanation that I can speculate on! GL