RE:Anktiva plus BCG Durable CR numbersthanks for the insightful break down Eoganacht. What I also find interesting is that they got approval with just 77 evaluable patients. That is significant because FDA apparently allowed them to just follow the 77 patients 3 years out.
I would think TLT would be given the same type of consideration for possible AA, at or below 100 patients; meaning no new confirmatory trial; follow our CR patients for 3 years.
If you look at the most recent TLT Corporate Presentation it mentions under Study Design: "Patient followed up quarterly for 2 years and then semi-annually for 3 years". That 2 yrs/3 yrs follow up has never been disclosed before (that I can recall) as part of the study design. I have faith that this new study time frame is a directive from FDA that we can obtain AA in the coming year or so and use the follow up 3 years as our confirmatory obligation to full approval.