RE:RE:RE:RE:Various thoughtsCome on guys, read the Oct 23 release;
"Theralase® is collecting the survival data for all patients, with central pathology laboratory validation, who have been previously enrolled and provided the primary Study II Treatment and who have demonstrated a CR or IR at any point in time, with duration of that CR or IR at 450 days, for submission to the FDA in support of a pre-Break Through Designation ("BTD") submission."
What this means is that 450 day data is good enough, but FDA wants central lab validation of the cytoogy results. It's not hard.
We will get to the promised land in time. Stay patient.