Absolute Rot: Cutting short the proof process means that marketed drugs may not work at all, and this would clearly be at the expense of people paying for something useless (think Aduhelm as an example of a regulatory failure) or, worse, harmful (think Thalidomide in Europe in the 1960s). They require that extra time to get the decision right, and cutting out that time carries an even heavier price to public health.
The p3 is not a safety trial, the safety of 273 is well established by several trials and years of data. So the cost of letting more people being irretrievably damaged by alz is real, and there is no offsetting safety benefit.
More Rot: Ultimately, the drug may work or the drug may not work "whether a peek occurs or not." But we won't know for sure if it works unless it passes the necessary statistical tests for efficacy and safety, and for reasons that have recently been explained here, passage of the efficacy test can be imperiled by an interim peek.
The trial was originally just going to be a 225 person Australia trial, the other arms in the EU, Canada and UK were added later. The 225 person trial should show effectiveness if AVXL has the goods. Even if not, the other trial arm could show it. In some ways combining this into an all or nothing roll of the dice is the big risk.
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