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Re: Luckytouch post# 376732

Thursday, 09/30/2021 2:20:02 PM

Thursday, September 30, 2021 2:20:02 PM

Post# of 403217
I agree, it shouldn't. However, the way the primary endpoint is defined/written, it sounds like we may be on the hook regardless for the success of that endpoint. For better or worse, sometimes just the way a protocol is written can affect the way the outcome gets reported and is perceived. That's why top clinical operations talent is imperative. I am anxiously looking forward to the results in a few weeks time and hoping for the best - this just seems like a potential oversight that could have broader implications for the market reaction (and path forward) with whatever the results end up showing.



Primary Outcome Measures :
Time to sustained recovery through Day 29 [ Time Frame: Day 1 through Day 29 ]
Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale with response sustained through Day 29:

-Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care (other than for per protocol dosing or assessments, as appropriate);
-Not hospitalized, limitation on activities and/or requiring home oxygen;
-Not hospitalized, no limitations on activities.
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