Replies to post #57842 on Anavex Life Sciences Corp (AVXL)

[XenaLives]

Was it anti-cholinergics that they used to give people in institutions? Just made them sit in a chair and drool all day.

[TrueTrades]

So it is a mix of donepezil and whatever else, and they are trying an ascended dose up to 60mg MTD? I believe the MTD for donepezil is 23mg? The study calls for pre-dosing of the donepezil arm at 5-10mg/day.

I went to compare to the P2a A2-73 study and was surprised to see no mention of donepezil, Aricept, etc. Other than the "...and to explore the relationship of ANAVEX2-73 as add-on therapy to AD standard of care."

I could have sworn there was something about 'stabilized on 5 or 10mg donepezil' in the eligibility section. I am starting to believe more that the add-on to donepezil was just a best scenario precaution as indicated by the preclinical models, which were comparable to the SOCs. The efficacy shown beyond the donepezil curve will negate it's inclusion in the outcome results. If the MTD is 50-60mg and the dose response maxes at 30-45mg with long term efficacy, we got a winner.

I would like to hear opinions on the rejection of the 12/522,761 patent and what we could expect from this once 13/777,471 is published.

TomP1: "Anavex views the most recent Office Action as within the ordinary course." Meaning, "We have a competent patent attorney and will secure the necessary IP in due course"? ;-)

GLTA
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