One detail that I just noticedIn the recent MDA there is a section that reads:
In 2016, Kamat et al. stated in the Journal of Clinical Oncology that the International Bladder Cancer Group (“IBCG”) recommended that, “Single-arm designs may be relevant for the BCG-unresponsive population. Here, a clinically meaningful initial complete response rate (for carcinoma in situ) or recurrence-free rate (for papillary tumors) of at least 50% at 6 months, 30% at 12 months, and 25% at 18 months is recommended.”2
The interim clinical data presented below meets or exceeds these IBCG guidelines.
When you look at the every one of the prior data releases, they have been close to the 50%, 30% and 25% target but not quite meeting all 3. This most recent data release is the first time they meet or exceed IBCG on all 3. I know some on this board were always set on the idea that reaching 25 patients was the trigger to apply to BTD. That never made sense to me as an absolute.
If they are using Kamat's reference points to buttress their BTD application then that may be one reason why they delayed the BTD a bit longer than they expected.