RE:RE:RE:RE:Phase11 450 days CR% data for BTD approval in Dec 2022...Eoganacht ... I agree that TLT will go on and submit data @450-days on the first 25 patients because that's what the rules were, right at the beginning. The FDA will recognize the potential of of treatment with the Ph. 1b p#5-6 patients and with those of Ph. 2 p#13-25, for many reasons:
- it is a novel standalone drug
- it's has much better efficacy than BCG
- it only requires 2 treatments (if not only one, like Ph. 1b p#5-6)
- it has neglictable toxicity
- it has high potency
- it doesn't discriminate among patients like immunotherapy drugs (Keytruda, etc ...) do
So the FDA wil focus on p#13-25 and maybe those from the undertreated group that might have shown an ability to turn CR despite the undertreatment. And they will most probably consider data from additional patients (p#26+) off-record, especially the CR @90-days. Possible that such data is being asked, for more considerations, given the undertreated ones.