Anavex Life Sciences Corp (AVXL)

[Investor2014]

I think so yes.

Example... I am making a drug that grows hair in balding males. We take a sample of 100,000 males 18-21 and they happen to all have brown hair. 90% of the sample regrew a full head of hair. What does this tell us about blondes or red heads, and anyone over 21? What is the confidence this drug would work in those people as well? Should the company be able to advertise that thier product can regrow hair in men?

Your example speaks to the labelling specificity requirement of the Benefit-Risk Assessment for New Drug and Biological Products FDA Guidance I included in my earlier post.

Under the FD&C Act, for a new drug to be approved for marketing in the United States, FDA must determine that the drug is safe and effective for use under the conditions prescribed, recommended, or suggested in the product’s labeling.The demonstration of effectiveness under this standard requires substantial evidence that the drug will have the effect it purports or is represented to have. Because all drugs can have adverse effects, the demonstration of safety requires a showing that the benefits of the drug outweigh its risks.