What the heck am I mistaken about? I said Anavex is running a Phase 2a trial and they are, they just added an extension on with the following:
Primary Outcome Measures: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: Up to 104 ]
First off, if Part A was a success why not end right there and do a double blinded placebo controlled properly powered Phase 2b trial with a primary outcome measure that includes efficacy?
Could this be the reason?
The FDA "ALLOWS" adaptive trial designs they don't "tell" companies to use them.
"To conclude, adaptive designs are not necessarily better than conventional designs in all trial settings. The merit of adaptive design over conventional design is to be judged on a case-by-case basis, looking at the overall clinical development plan. An adaptive design should be resorted to only when one is convinced of its merits over a conventional design. Further, implementation of adaptive trials is often fraught with challenges. Also, many areas of adaptive design still remain controversial and some regulatory agencies are still skeptical about acceptance of such designs. This explains why despite their attractiveness in terms of cost-efficiency and flexibility, adaptive designs are still in their infancy worldwide. Thus, while taking proactive measures towards implementation of adaptive designs regulators such as FDA are also leaving the industry with a word of caution: to allow time to build a better knowledge – base and understanding of adaptive designs before moving forward with their implementation."
Neurotrope's trial actually has a chance to "fail quickly ", Anavex's (2a partb extension) only has to achieve a few adverse events to meet its primary outcome measure. It's a guaranteed success based on that, now isn't it?
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