RE:RE:Let's say BTD is a given From a Dec 2023 video, Roger said he expected to file a pre-BTD in Q1. That a response to this is "2 to 3 weeks". He went on to say that if there are no issues to address, a formal BTD would be filed in the same quarter. FDA response time is 60 days.
Obviously there was a delay as the pre-BTD just got filed. My guess is that the "events had to be addressed with 3rd party validation, which has happened.
We now have an additional 8 months of data.
I read that 20 to 25 patients were needed for BTD. We now have 68 at the 90-day mark. 75 in total.
I would assume the BTD application is already filled out. Adjustments will be made based on the response to pre-BTD.
If we are lucky, a formal BTD is filed by the end of the month.