Post by
DJDawg on May 03, 2024 12:04pm
latest news release
The newest release is interesting in that it is one of the first to NOT mention pre-BTD and only mentioned BTD approval.
Possibilities
a) vague wording and cannot read into it. (most likely)
b) pre-BTD has been done and they got the feedback to go ahead and submit BTD.
I would love it to be b.
One thing about pre-BTD is that I've never been convinced it is a thing in the way that people say. The BTD process allows meeting with FDA to run through the application and get feedback on whether it is good to go. I think that that part is what they have been labelling pre-BTD.
My thought/hope
- they ran it by pre-BTD staff to see if ready in 2023 and were told that it looks promising but that they weren't ready for BTD till got a,b,c
- they got enough a,b,c that they ran it by pre-reviewing staff again and they said that you are good to go but make sure you finalize these details.
- so perhaps what they have been calling pre-BTD is done and they have enough hope that they are hiring extra staff to run down details.
One thing about medical research in the setting where I work is that for them to get patient's to sign forms for the extended data follow up, they need to catch the patient. You can't cold call them. Not allowed. In my area the research person such as myself sees when the patient is coming and catches the doc before they go in and says, can you ask the patient if they will give permission to chat with me after the visit. They do the visit and come out and go to a sideroom for research signatures and explanations. You have to do all that because if you don't it just doesn't happen.
I wonder if they are having enough trouble catching the last few patients that the new hires are being tasked with literally going to the sites and being there for the patient visit to catch them like this. Docs are terrible at doing any research paperwork as they are just too rushed in clinic. The BTD is probably needing the full extended data set on the 20CRs.
These kind of thoughts are my copium. :)
Comment by
managementfirst on May 03, 2024 12:29pm
Very thoughtful, but RDW just kept everything delaying, cannot rust him.