Peeking does not negate a trial, but it makes for a riskier bet at the time of the peek (less data to use, so higher randomness in the result). If we looked today, there would not be 450 completed trials. The n of 450 might just be 270. Well, why didn't AVXL design a 270 person trial -- we wouldn't have to wait until next year, right? The reason is the trial would be "underpowered." The outcome would be shakier than the statisticians recommended. That makes it harder or impossible for the trial to be pivotal. As it is, a 450 n as designed for the 2b/3 is a very small set to use as a pivotal trial for such a major indication as Alzheimers. Those trials can be in the thousands. SAVA is planning two trials, one of 1000 and one of 600. Perhaps they will need higher numbers because they anticipate a less dramatic clinical effect. Or, put another way, maybe Missling is so sure of his hand he is willing to go to the FDA with only 450 subjects. But even he is not inclined to try persuading them with, say, 270. We want an uncontaminated n of 450. That will be hard enough.
If he has to break the glass and peek in the face of a bid of $10B, the chances of staying independent will drop and the chance of a bigger takeover price will increase. That's because the original 2022 readout date may no longer be pivotal. So I hope the threat of an early readout will give Anavex more ability to stay independent by deterring some bidders.
He has other defenses, as well. He's done a great job to get us this far.
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