Excellent post Ice.
The FDA chief saying: "....in, rare diseases we need something now, not later," says to me, that with MLP's impecable safety and tolerability levels, they might consider allowing use, on compssionate grounds, whilst the trials are running.
I imagine those sufferers who missed out on being enrolled in the studies, feeling pretty dejected.
PAA, A New Dawn , FDA ODD Approval and Entering Phase II MND Trial, page-378
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