Biases or not, a new type of drug is going to impose a steep learning curve upon its reviewers and, if they have difficulty mastering all that information, they will not be comfortable in granting an approval.
The FDA staff will not be biased against approving anything new, per se, but they will be uncomfortable with their own uncertainties. It is therefore incumbent on Anavex to help them master their review assignment -- and that will take more documentation and more explanation in the NDA regarding how the new dots connect. That equates to more time spent in the pre application phase, which is where we presently find ourselves with the likely voluminous AD data.
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