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.
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.
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.