This is exactly the case. 22% difference of the FDA vs the advisory panel makes for a great headline.
However, it is very different to our situation, where the question needs to be "how many majority confirmed advisory panel recommendations for a drug already proven/used in a 1st world country has the FDA rejected".....
Please @thrasher, remember that there is a real world consequence for 1000s of kids in America if this drug, which is safely used in Japan, is not approved. These kids currently have no approved treatment options, this drug atleast gives them a chance and the FDA knows that.
GLTA
CRL or Approval???, page-46
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