RE:RE:Anktiva plus BCG Durable CR numbersHi Donein - Your post is really thought provoking. You suggest that maybe we could get AA in the next year or so and this makes a lot of sense to me. ImmunityBio just got approval based on 77 patients and their trial isn't complete so it looks like a kind of accelerated approval.
In our case at the end of March we had 52 patients who had received their 15 month assessments. By the end of the year those 52 patients should have had their 2 year assessments. If our 2 year CR rate for those 52 patients is much better than ImmunityBio's 2 year 25% CRR maybe we could also end up with conditional approval. And maybe we could have it in early 2025!
Donein25 wrote: thanks 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.