MSB - What went worng?, page-2

On all thread there has been good logic for many evaluation.
i am totally frustrated and angry.
i can't agree the FdA acted appropriately.
there has been many example of approval for other drug and treatments bases on very flimsy data and unsafe.
yhe resubmission was for kids . The FDA have responded a melded in kind as a crl to an adult submission. And not directed towards kids. It should be clearly AA for kids.
and as Si said and expected with an additional trial for adults.
even commentary at the CC by journo stated the same.
and they also said FdA did move the goal posts again.
to which MSB should go to legal action as there is nort to say they won't do it again and again.
they did it with the crl mark1.
and endpoints with the Covid trail too as endpoints there should have been admended due to the parameters entering the trail had completely changed so highly unlikely for a positive outcome as based on prior parameters. Think it was not paid for or fully designed by MSB.
theer seems to be fear for MSB not to take on the FdA in getting them totally offside.

Also pointed out by other posters of new US fed legislation re new and faster approvals for cell therapy pathway. Yet not contested by MSB as FdA did not adhere to that new legislation.
the. FdA has not adhered to it own premise. If it works and safe