… the results of randomized outcome studies that look at things like the accumulation of disability in the preceding years, a lot of patients are going to become disabled. And so The agency has made an effort over many years to try to get these products when they determine their baseline safety and out to patients sooner. and then try to fully evaluate the benefits in a real world setting. And I don't think anyone, you know, argues with that doctrine. And I don't think the current leadership does. (06:58–07:06)
CLAIM
Asserts that the agency has worked to expedite product availability after determining baseline safety.
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