Nicole Hardy The FDA's move to examine the new safety data more closely makes sense, though it will likely delay any benefits for those counting on the combination therapy.
Rachel Meyers Kind of telling that they're still holding onto that one post-MI study though. Guess we'll see if there's a specific subgroup where this actually works.
Elena Vasquez Intrathecal delivery is going to be a barrier for a lot of families depending on where they live. Access to specialized centers matters just as much as the approval itself.