That is in the “risk factors” section and they also explained, as they did in their presentation how they dealt with it. The purpose of the Risk Factor sections of SEC filings is to warn investors of things that MIGHT happen, not what will happen. They cover all kinds of bad things and if floods or hurricanes were a big factor it would cover those too, to ensure that in any court, it could be said that the “investor had been warned” about potential risks and they knew and accepted those risks. This is not a bank CD.
We all know they have not received product marketing approval, which is different to saying that the change in the Statistical Analysis Plan was submitted and approved before they unblinded. Don’t
confuse naive READERS.