Anavex Life Sciences Corp (AVXL)

[nidan7500]

Mid evil methods:

1. Trial Design

All patients in ALS trials should receive the best standard of care, and no patient should be denied effective therapies in order to be randomized to a placebo-only arm. Various strategies can be applied to expedite ALS trials and minimize unnecessary exposure to placebo. For example, master protocols (which use a single infrastructure, trial design, and protocol) allow for the simultaneous evaluation of multiple drugs, with a common or shared placebo group, and have the potential to greatly expedite the development of new drugs. Sponsors should also consider adaptive designs10 (including the use of Bayesian features) and enrichment strategies.11

FDA recommends the consideration of add-on designs, in which a treatment previously shown to be effective for the treatment of ALS is given to all patients participating in the trial (i.e., no patient receives placebo alone), with patients randomized to the added investigational drug or

https://www.fda.gov/media/130964/download

Compared to: "Hypothetical- take an A2-73 -10 mg and call me in the morning". Would also like to see something from the FDA that says.."And this is what we learned from our previous protocol and what we are doing to improve our methods."