Replies to post #503509 on Anavex Life Sciences Corp (AVXL)

[Kentucky123]

After reading all your past research you think the data is lacking? Please explain.
You must have your ear to the ground or I have misread your research or lack comprehension.

"Our current position and macro environment are practically unprecedented, however."

Could you add more color to the above. I do not understand.

[frrol]

Correct. The range of outcomes for regulatory approval are broad - from full denial to full approval - and can be viewed as a continuum. There is much in between, including approval with restrictions. Example: "approved for patients only with a level of AB 42/40 no more than XYZ". Then there are the possible coverage/reimbursement restrictions.

The climate for AD drug approval has changed over the last several years with the shift in views on AB, choice of endpoints, utility of biomarkers, and pressure to approve new AD therapies in Europe. The changes are favorable for our drug, though that doesn't guarantee an approval (of any type). It just helps our chances.

CHMP opinion can come as early as November, though can take longer if there are open MAA issues the company does not or cannot adequately address. For the moment, watch the CHMP process updates. As always, ignore messageboard knuckleheads.