Distressing Statistical Issues and Class Action Lawsuit Thoughts
AVXL used a CRO who supplied the analyses. The pre-specified co-primary analyses of difference of means on these two endpoints are the VERY FIRST topline items the CRO gives to the sponsor; this is obviously standard as these pre-specified analyses are key to approval for pivotal trial. Every CRO does this, per the statistical analysis plan.
It is impossible for AVXL to not have both these results from the CRO (again, the VERY first thing a sponsor receives); yet, AVXL mgmt chose to disclose only ONE of the two. If the results are unequivocal as the press release headline publicly states, why hasn’t ADCS-ADL co-primary difference of means been reported? Why would you NOT report the other if you said the results were successful? There is zero logical reason to NOT show it once you’ve legally committed to your press release.
AVXL has had more than 168 hours to unequivocally confirm this with us shareholders, yet they bizarrely choose not to during the most critical time in the company’s lifespan, despite physically having such yes-or-no answer from the CRO since Day 1 of receiving the data last week. The only logical reason is that ADCS-ADL difference of means failed its primary pre-specified analysis.
If the press release legally and publicly states, “Met Primary and Key Secondary Endpoints”, and they have failed, this would undoubtedly result in a Class Action Lawsuit for misleading us shareholders.
If mgmt counsel attempts to defend this saying that a responder analysis (set by their arbitrary standards) succeeded and that constitutes primary endpoint success, nowhere in the history of AD development has an arbitrary responder analysis been acceptable as an endpoint in a pivotal study for AD development by the FDA. For pivotal AD endpoints, these are cognitive and function endpoint analyses based on difference in means. Missling on January 10th, 2022 characterized this 2-73 trial as “now in pivotal study in Alzheimer’s disease”, so it is unequivocal that this is a pivotal trial. This recent topline press release said the pre-specified analyses were successful; to spin it would be completely misleading.
The silence is deafening from AVXL mgmt, especially considering the legal stakes for a class action lawsuit here.
