That is utter nonesense gassy
If MRI is set up as a biomarker as a secondry endpoint then fact it is accepted by the FDA
infact the FDA are promoting new trials to engage further with MRI in clinical trials
and personally i believe it is what got Duvyzat over the line with the FDA when they recieved Marketing approval
UF researchers led by Vandenborne, the director of neuromuscular dystrophy research program ImagingNMD, have pioneered the use of MR biomarkers to capture highly accurate and noninvasive measures of muscle changes in children with Duchenne. Using MR measures in studies like these overcomes the limitations of traditional methods of determining study outcomes, such as measuring a child’s walking speed or other timed functional tests, Vandenborne said.
i wouldnt be surprised in the future if MRI does ot become the standard in the likes of DMD trials as it says
Using MR measures in studies like these overcomes the limitations of traditional methods of determining study outcomes, such as measuring a child’s walking speed or other timed functional tests, Vandenborne said.
and yes it is very much accepted by the FDA and they are promoting so
The only reason that our data was unacceptable in the 2A is because it was not set up before hand pre trial to be used specifically as a biomarker
there is a difference if it is set up in the trial investigation then it can and has been used as a biomarker as i said as Duvyzat have proven their results were backed in by this process and showed clinical change
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