Laurent, The sheer size - success and power of Novo Nordisk - gives reason to believe that the project aimed at AZ has been thoroughly investigated before they go public with this announcement.
I noticed at one point numbers mentioned - that equals Brave. So maybe' - If the results (taken they show real benefit in preventing dementia/AZ) will be sufficient seeking approval from FDA - after the new rules.
It would not be bad to 'be approved before Novo Nordisk - in the fight against one of the worst diseases that can affect humans.
Finally, in a post-hoc analysis of data from three large cardiovascular outcomes trials conducted by Novo Nordisk (LEADER, SUSTAIN 6 and PIONEER 6), which included 15,820 patients with type 2 diabetes with median follow-up of 3.6 years, a total number of 47 people were identified with development of dementia, of which 32 were on placebo and 15 on GLP-1 (liraglutide or semaglutide). The rate of developing dementia was statistically significantly reduced by 53% in favour of GLP-1.
My take is that all of these injectable or infusion based AD drugs have some very serious side effects and are a mistake for the FDA to approve. What AMRN needs is a BP to acquire it in order to reformulate it in a way that gives it patent protection, in order to pursue new indications such as cancer & AD. Hoping that Denner is working to insure such a scenario plays out. I wonder why there have been no retrospective studies on AD given that the drug should have been used long enough by enough people for such determinations. (My own opinion is that an honest study of Vascepa & AD would show effectiveness as would one for Vascepa use and cancer.)