Anavex Life Sciences Corp (AVXL)

[nidan7500]

It’s not unambiguously clear whether lecanemab meets the litmus test CMS imposed, namely answering the question CMS posed in the NCD in the affirmative: “Does the anti-amyloid mAb meaningfully improve health outcomes (i.e., slow the decline of cognition and function) for patients in broad community practice?”

Also, even if CMS relaxes restrictions, in the end lecanemab’s uptake will also hinge on whether physicians and patients find the data convincing. For example, while some clinical neurologists believe the data posted by the sponsors is promising, others have said they do “not foresee much meaningful change in patients' lives.” For lecanemab, as for any medicine or healthcare intervention for that matter, statistical significance does not necessarily imply a meaningful drug to individual patients and their caregivers.

https://www.forbes.com/sites/joshuacohen/2023/01/02/with-fda-accelerated-approval-of-alzheimers-drug-lecanemab-likely-january-6th-discussion-turns-to-price-and-reimbursement/?sh=27e7c01e3969
FDA credibility (such as it is) will be on the line as a direct consequence of this decision. They do not need to panic...but they probably will based on PR's like this.