Replies to post #303116 on Anavex Life Sciences Corp (AVXL)

[boi568]

Thank you for that background.

It does not appear, however, that Missling shares your thoughts regarding 2-73's odds (five percent) for a one-trial approval. He has his reasons, which probably include (1) a likely prior Rett approval; (2) supportive improved memory results in PDD 2b/3 (at minimum); (3) strong safety data, including the multi-year, small sample AD OLE; (4) the possibility of other rare disease successful trials; and, (5) even the possibility of a prior TGA approval. Finally, AD is a serious disease with drugs that offer no more than symptomatic relief -- not dissimilar to the case for oncology one-trial approvals. A five percent prediction is akin to a historically-based, one percent prediction for success in the current AD 2b/3 trial. It fails to take into account differences in the surrounding circumstances that favor a more immediate approval of 2-73.

Missling, a cautious CEO, is not signaling his expectation to undertake a second Phase 3 AD trial, or he would not be choosing the term "pivotal," as he has for other ongoing or planned trials that can be expected to support NDAs.

[blu_1]

What do you think Doc, 6 or 7 more years of waiting til *possible* approval for Alzheimers? Do you still set fda approval for Alzheimer's at a 25% chance?