Kun Jin has been on the payroll for 15 months. WTF is he been doing? In case Missling is not aware WE ARE IN THESE INVESTMENTS TO MAKE MONEY. NOT TO HERE HIS BS EVERY 90 DAYS OR SO. PDD was stat sig 3 tears ago. It is almost like BP is paying him to slow walk this.
Excellent post/thinking thanks Jonjones325. FDA - EMA may also see an incentive to move on considering the building academic (as recent re: Stanford Pub.) presents evidence questioning the AD Amyloid thesis. It is truly time for all to move on. . Let AVXL RWD-RWE provide additional evidence CNS treatment efficacy.
Anavex had no choice in going with the Centralized Marketing Procedure. It is compulsory for drugs that treat neurodegenerative diseases.
That is not to minimize the importance of obtaining the go ahead.
1. Centralised authorisation procedure This procedure results in a single marketing authorisation that is valid in all European Union countries, as well as in Iceland, Liechtenstein and Norway.
The centralised procedure is compulsory for new marketing-authorisation applications for medicines for human use in the following cases:
human medicines for the treatment of HIV/AIDS, cancer, diabetes, neurodegenerative diseases, autoimmune and other immune dysfunctions, and viral diseases; medicines derived from biotechnology processes, such as genetic engineering; advanced-therapy medicines, such as gene-therapy, somatic cell-therapy or tissue-engineered medicines; officially designated 'orphan medicines' (medicines used for rare human diseases);