RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:Keep patient, maybe we are at last step to the final victoryhttps://stockhouse.com/news/press-releases/2024/05/02/theralase-r-expands-clinical-team
So my hunch is that the following happened
1. Preliminary Breakthrough Therapy Designation Advice Request was held and the advisor didn't say NO or YES but rather, maybe but you need more information (central lab and further out data) to compensate for lack of biopsies and to just be more confident.
During the conference with the FDA, Theralase may have been advised that a definitively better durable response at 24 months would clearly demonstrate an improvement over available treatments which is a requirement for BTD and (hopefully) AA.