RE:From the April Newsletter
Eoganacht wrote: "Theralase® is currently focused on working with its Canadian and US-based CSSs to enroll and provide the primary Study Treatment for up to 7 additional patients in 2Q2021 for a total of 20 to 25 patients enrolled and treated in Study II. Theralase® plans to compile up to the 90, 180, 270, 360 and 450 day assessment data (urine cytology and cystoscopy) for these patients with the intent of submitting this interim data to the FDA for consideration of Breakthrough Designation (“BTD”) approval."
Hi Eoganacht...As written, I interpret "submitting this interim data" to reflect a collection of data that is occurring along a continuum....that is, occurring at different assessment points (different points in time), which explains why they specifically referred to each assessment period (I.e. up to the 90, 180, 270, etc.)... all the way up to the 450 day assessment. If a BTD decision was primarily dependent on 450 day data, why even specify in the news release all of the other assessment times? Either way, I hope you can get clarification on this from the company. Best of luck...