First of all a very big thanks for bringing that question up at the AGM.
I don't think a cross over trial would be that complex to design and those patients that cross over would in fact be those that would be eligible for a recruitment in a trial that SI described, could actually be better as they most likely would not have been given many of the other drugs that are experimental other than those given as a sedation for ventilation . It is possible that those drugs have a negative impact on outcomes as well.
My understanding from SI was that the trial design was a little bit undecided. Leaving it a bit open for discussion with the FDA, perhaps his team will bring forward several trial designs for the FDA to consider and set suitable endpoints. Would also be a little hesitant as Novartis would probably want to add there exspert
opinion in as well.
Good luck all and stay safe.
Ann: CEO Presentation to 2021 Annual General Meeting, page-48
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