The results are solid and a lot of the selling was prompted by AF and shorts, plus it was not clear from ct.gov that the measurements of endpoints and the primary endpoints were changed in response to FDA advice, and prespecified (according to what I understood Missling said in the CC), hence the change in measurement of the endpoints were completely appropriate, and per Missling, the successful results they achieved with these measurements were much harder to obtain than the prior measurements. Moreover, if AVXL had used the prior measurements they would have obtained a similar outcome or even better according to Missling's estimate.
Based on what Missling stated in the CC, the FDA will appreciate this change in measurments that coupled the outcome to the other endpoints. In other words, it makes a stronger case for approval than AVXL would have had using the prior measurement of the endpoint. And, if it was prespecified, as Missling stated, then it is not going to be challanged as cherry picking the by the FDA that recommended the change.
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