banter and General Discussion, page-7568

@dachopper

re your last 2 posts:

Different management of FDA is the thing. Marks is making it clear he wants to get on top of the agenda and have the FDA acting in a consistent and logical way. There already articles about how the FDA is holding back innovation and this is a prime example.

You can see he's alert to the repetitional damage that is occurring from the previous decisions not just limited to those re MSB, from the Endpoints interview.
I wish people would read that carefully and stop trying to take pot shots on trial design or the reason why the FDA has agreed to not apply RCTs to the paediatric aGVHD cases. So this means they will apply a well designed trial to the adults.

I do wish posters wouldn't assume that it's only one issue. The whole context needs to be looked at including the baseline of mortality 85%.