Trial completion of both? Nader said yesterday tha
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Posted On: 07/05/2020 12:33:46 PM
Trial completion of both? Nader said yesterday that he wanted to have the trial data for both trials to submit to the FDA. We have completed one trial and he was unsure if we could use mid point trial data for the Severe/Critical. If he wants to submit this trial data together by end of July he would have to get some kind of agreement or be allowed to by the FDA to perform the mid point analysis. If FDA isn’t playing nice and that doesn’t happen. Where does that put us on a timeline? July? August? September? Going it alone with just mild to moderate? Waiting to submit still together with Severe trial?
The severe trial having a higher 390 patient completion number could put us a couple of months out on a timeline if we wait until completion. It seemed like in the past it was a lock that we could do a mid point data unveiling and now that has potentially changed? Wonder why? I realize that high numbers are always better.
Does anyone have a better idea of a timeline that both unblinded trial data can be unveiled and presented together still?
The severe trial having a higher 390 patient completion number could put us a couple of months out on a timeline if we wait until completion. It seemed like in the past it was a lock that we could do a mid point data unveiling and now that has potentially changed? Wonder why? I realize that high numbers are always better.
Does anyone have a better idea of a timeline that both unblinded trial data can be unveiled and presented together still?
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