Here's one I don't believe anybody has talked about.
I agree Antihama. There has been a discussion here about data the company has hidden; if the RWD from compassionate use was bad, wouldn't they hide that, too? While they don't give numbers it would be weird to say that it would helpful if in fact the data showed no significant benefit.
Agree Didn't take much notice of it . I wonder if the delay has been because of updates/modifications needed in the original application to be able to use RWD as initial application obviously would have been based on ECA with supporting data from compassionate use . This delay can't be explained just by RFI's in my opinion :
What that means is that they dont plan on applying for US approval for many more years. The fact that they are considering compassionate use program in the US indicates that BLA wont be submitted for many years.