it is a heterogenous disorder without clear biomar

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it is a heterogenous disorder without clear biomarkers to track and without even clear definitions.

I believe that LH trials could be a quagmire. Expectations of what constitutes success need to be determined by the FDA.

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That seems to be befuddling the FDA. From my viewpoint the end goal should be alleviation of symptoms. Primary endpoint should be decrease in primary symptoms vs. placebo. The FDA prefers scientifically measurable endpoints vs. how a patient feels. On some symptoms like oxygen flow that can be tested on something like brain fog you might have to base it on patient descriptions but setting those endpoints should be fairly straightforward.