In the Aus biz interview, Silviu suggests that the “large” Novartis partnership deal shall be closed soon. The OTAT meeting shall clear the way for the approval of potency assays which shall be integral to the phase 3 trial which is already designed.
So to recap, the COVID ARDS phase 3 trial shall be confirmed immediately or soon after Novartis partnership deal is closed.
If we have a properly designed confirmatory trial, I would put the chances of an early stop due to efficacy being more than 50% chance. An EUA is within sight and there might be more color shortly on the design of the trial and interim analysis points.
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