Thanks for this - I never would have read through to page 10 myself to find the FDA's new recommendations on efficacy outcome definition.

Do you have any idea why the FDA would prefer a longer outcome period for critical than "non-critical" cases - 60 vs. 28 days? Are they describing a different clinical course?

Outside of follow-up period, we match this document's 5 categories pretty well: We have mortality and can compute "alive and non-ventilated." Their third bullet is precisely our "7-point ordinal scale." Their fourth bullet isn't our S.O.F.A. score, but it is based on "first occurrence" or various thromboses, with stroke and heart failure added in. We probably have the extra data. Their point 5, "time to recovery" doesn't seem relevant.

I'm wondering if the FDA under somewhat-iconoclastic Woodcock is asking for data directly so they can create apples-to-apples comparisons of various trials. To hell with stated endpoints!

I'm not too worried about not having 60 day data in this case - censored data techniques (Cox model) uses 60 day data on all patients that have it, 42-day data on those with only that much, etc.

I'm very interested in the clinical meaning of wanting a longer follow-up for critical patients. Ideas?