Anavex Life Sciences Corp (AVXL)

[frrol]

The failure of the Excellence Rett trial was not a consequence of its size. The trial size was increased, and after consultation with the FDA. It was much bigger than our previous trials. It simply missed its endpoints, some barely, some definitively. This is unfortunate, and very common. And trial size does not increase (nor reduce) endpoint scores. It simply improves their validity. It also doesn't reduce type 2 errors. Incidentally nor does it increase type 1 errors.

2-73 may be therapeutic for Rett. We just didn't prove it based on regulatory statistical standards. We will be arguing that there were particularities in the placebo data, which is not a strong argument for regulators. We'll also be providing the circumstantial evidence of OLE participation and caregiver anecdotes. It's a tough row to hoe and we are very likely facing a full phase 3.

Watch for news in the coming months on the long awaited PD, FX, and "undisclosed" indication starts, and the 3-71 Schizophrenia start. Sometime this year we should also hear about the AD paper. Our peer-reviewed paper on 3-71's phase 1 took two years from TLR, which shows how long it can take. From our last CC it appears the AD paper was written and is currently being reviewed. It then awaits submission and publishing.