RE:RE:RE:RE:pre-BTD and BTDDJDawg wrote:
It is definitely a bit of a guess but based on the fact that in the area I work we tend to put emphasis on having a total of 1 yr follow up from the last "treatment". Maint at 6m means that following to 18m is what would be ideal.
The recent trial modification approval was interesting in that they asked Health Canada for approval to follow up a bit further on the CR patients and use a central pathology lab to confirm results. It feels to me that that Health Canada request is in order to get data that they have been asked to put on the BTD application.
Yes, speculative. Doesn't change anything really other than helps explain what missing data is needed for BTD that they don't already have on files.
Regardless, I still believe in the science (management less so) and continue to hold.
Dawg, I'm curious if you have any thoughts about the amended optimization treatment and whether this would impact AA timeline (assuming all goes well and the company receives BTD approval)? My concern is whether the FDA would want to see a measurable number of this new cohort advance toward 450 days before approving AA.