Replies to post #452976 on Anavex Life Sciences Corp (AVXL)

[Investor2014]

And you might be doing that more than once each time adopting the same stance.

[Talon38]

Steady/Investor....drug approval by the national agencies is a very complicated process and has many factors of which trial length and size are just two of the variables. Below is a synopsis (long) of the FDA decisions on NDAs going back to June of last year. Some of the trials were short and a few had relatively small numbers of patients, A number of the drugs dealt with rare diseases/conditions. Some were rejected because of 3rd party manufacturing deficiencies. A number of them had to have continued review of data or requested such. All in all the NDA process was not easy and required some background knowledge and gamesmanship of the process by the submitting company (which we have). This is a good primer for Anavex. By the way, our prime example, Keytruda, was mentioned several times by itself and in combination with other drugs. A competitor for 3-71 falls by the wayside at the beginning of the article!
Again, this is long and should be perused when you have time.

https://www.biospace.com/article/biospace-fda-decision-tracker-2023-biomarin-celltrans-pfizer-and-opko-health/?utm_campaign=Newsletter%20%7C%20GenePool&utm_medium=email&_hsmi=296268142&_hsenc=p2ANqtz-9K3fctEhuwvmdJM7bsesYIlp_APuUf_nSFmd69A9bdtG2Paqj5ktCWa_SPqiJsrTTUjslAr3vqTJwlEsnkw6op16xiiQ&utm_content=296268142&utm_source=hs_email