Anavex Life Sciences Corp (AVXL)

[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.