Anavex Life Sciences Corp (AVXL)

[sokol]

Joseph:

Cost of a drug is not a factor in re FDA approval. However, it is a factor in the EU, Japan and Australia, which I think advances Blarcamesine’s chances of approval in those areas of the world. This ,cost, is one of several reasons why I believe Anavex should focus on early approval overseas, as I said in a post yesterday.

The U.S. - FDA is biased towards big pharma. I say this based on published research and personal experience. That may be a reason why the FDA is not concerned with costs.

In any event, Anavex, I believe has better odds of approval in Australia, the EU and Japan (assuming Anavex finds a suitable partner in Japan).

Here are a few citations to support what I say:

1. Affordability of medicines in the European Union

Abstract

Background

Medications and their prices are key issues for healthcare. Although access to medicines at affordable prices had been specified as a key objective of the European Health Policy, it seems that these goals have not been achieved. Therefore, we attempted an evaluation of affordability of selected medicines at full prices.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5328386/

2.  Pharmaceutical Sales in Japan:

Balancing Innovation and Cost Control

https://ashpublications.org/ashclinicalnews/news/6030/Pharmaceutical-Sales-in-Japan-Balancing-Innovation?searchresult=1

3.  The Pharmaceutical Benefits Scheme (PBS) **lets Australians use lots of prescribed medicines without paying full price**. The PBS is part of the Australian Government's National Medicines Policy. The National Medicines Policy aims to balance the need for medicines with good health results and economic limits.

   [Pharmaceutical Benefits Scheme (PBS) - Healthdirect](https://www.healthdirect.gov.au/pharmaceutical-benefits-scheme-pbs#:~:text=The%20Pharmaceutical%20Benefits%20Scheme%20(PBS,health%20results%20and%20economic%20limits.)

4.  New research suggests biases play a role in FDA drug approval

Innovative drugs are sometimes held up due to old-fashioned human biases.
.....
KEY TAKEAWAYS
- When new drugs are similar to popular drugs on the market, FDA approval takes up to 75 percent longer.