Anavex Life Sciences Corp (AVXL)

[Steady_T]

Here is a bit more from that article that goes in to the FDA's thinking in more detail.
Given the very low SOC for AD maybe they would apply the one study consideration. Looks to me that will depend on how clinically meaningful the AD results are.

Back in the 1970s and 1980s, the US Food and Drug Administration (FDA) made clear that at least two adequate and well-controlled studies were necessary to establish a new drug’s effectiveness, except in only the rarest of circumstances.

Then in 1997, the Food and Drug Administration Modernization Act was passed, and Congress clarified that FDA may consider “data from one adequate and well-controlled clinical investigation and confirmatory evidence” to approve a new drug.

But in guidance from 1998, FDA says that its reliance on only a single study “will generally be limited to situations in which a trial has demonstrated a clinically meaningful effect on mortality, irreversible morbidity, or prevention of a disease with potentially serious outcome and confirmation of the result in a second trial would be practically or ethically impossible.”

The agency also explains the persuasiveness of using two studies versus one.

“Whether to rely on a single adequate and well-controlled study is inevitably a matter of judgment. A conclusion based on two persuasive studies will always be more secure than a conclusion based on a single, comparably persuasive study,” the guidance notes.