Re: Perhaps a simpler explanation for request of additional MRI on other boys on eteplirsen is being overlooked
alt, haven't you considered that the FDA is doing its best to prod SRPT into a more complete submission? The company is using MRI data on the twins to explain why the dystrophin they produced didn't yield the same benefit on the 6mwt as the other ten boys in the trial by pointing to their MRI data. The FDA may be saying that showing the MRI data for the other boys would make their dystrophin argument a bit more solid if they showed the other boys hadn't lost the same degree of muscle when comparied with their individual MRI results.