“ Did I miss our application for FDA approval for the drug our CEO said met primary and secondary endpoints 18 months ago.”
Historical, never seen before Alzhiemers Ph 2b/3 trial results all stemming from a new age Fda ph 2a trial design including practically zero sideffects and nada from the FDA except acceleration of toxic MABS.
On the other hand the EMA sees the results and “pulls us in to file a MAA”. (paraphrased) Per Dr. Missling they are working together to work out any technical bugs that may hold up the application process.
Clearly seems like there are different sets of priorities between agencies. One values their citizens and look for safe, effective, easy to administer drugs. The other panders to big pharma and the almighty dollar.