Ann: Update on BLA for Graft Versus Host Disease, page-331

near the end q&a, re lenght of time to get the Adult trial up and running.... said we have 40 sites to look at and gettin participant will be easy as patient have no other treament available (sadly no choice other than die it would seems), lenoght of trial would be short compared with a suggest 18-24 months. primary it would seem becauser of present data in the worse case patients, so to form quick endpoint would also be easier obtain early.

unless. and but... the FDA changing goal post again...

all of the information flooding in... to me suggests clear clear legal action... the FDA can not continue to change their minds about endpoints of advice confirmation they want and be give only to say do it all again...

as disgusted but others and me at times over a long period, who his the sheriff for FDA activity... who pull them into line...
the ony thing i see is a bit of change in those that rule wiht the FDA, but they seem to act it odd outcomes

the public can submit objection and recommendatiion but.. long drawn out and need to be a legal eagle to get through that process of application to be heard, and get lots of signature before gettgin a look in and then FDA can avoid for years or ignore as how is to take them to task if they drop the ball in preformance