Replies to post #452597 on Anavex Life Sciences Corp (AVXL)

[Reyeton]

Sorry to say but Missling is a zero either way. Why does it seem Australia isn’t much of a player anymore? They provided a lot of needed money to get clinical trials started there years ago. Doesn’t it seem Australia should be in line to have a say in granting approval or not for AD. I try to figure it out and come out with zeros. Why is Australia not in line to grant approval. Just asking. With company higher ups having no apparent trouble standing in line to reap financial gain, many if not most investors have been standing in line for more transparency from the company for years. What once seemed like a great company continues to be destroyed by management, IMO. Prove me wrong and get this product approved.

[Talon38]

Steady....still think that the Rett's parents and the over 90% of the little girls who are carrying on with our drug not to mention the adult patients, will give the FDA incentive to either approve a submitted NDA or outline a P4. They have approved other troubled submissions in the recent past and in our case we have a "safe" drug, not like "Aducanumab" which Biogen just dropped (never approved by the EMA). We may get some help from a future partner if they are in the wings!

[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.

[meds4life]

re: It still remains to be seen how the FDA will react to those (Rett) trial results.

DO we know for certain that Anavex is in discussion. with the FDA about the Excellence results?