You are right and so is Doc.
The numbers in the OLE are a fraction of the initial cohorts and that really diminishes the impact of the OLE data in the eyes of the regulators.
Having said that, the OLE is very suggestive of the conclusions that Anavex is making.
I use the word suggestive because it would take a full on trial to prove those conclusions.
Even so, I think the regulators will take notice of the OLE data as it does show that for some people (those who stayed in the OLE) long term use of 2-73 has a continuing impact on disease progression. The difference between the short interruption and the longer interruption is also supportive of continued use of 2-73.
The approval decision will be made on the basis of the trial data, the OLE will be considered supportive at best.
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