Replies to post #415000 on Anavex Life Sciences Corp (AVXL)

[Investor2014]

And just one important PS!

Just in case the, according to some very unlikely, scenario occurs where Anavex does not gain Accelerated Approval from their P2b AD trial, then it makes good sense to have a P3 PM AD trial already on the go!

One with A2-73 and the other with A3-71 - yeah that's gonna cost some LPC dosh!

[abew4me]

Read this other post by Steady.

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=171874266

[tschussmann1]

Well researched and thought-out post. So, the bottom line: what do you think the timing impact of AA with concurrent confirmatory P3 is vs AA with P4? Can they actually be the same as far as the time A 2-73 would be commercially available, or is it likely that the AA/confirmatory P3 process would result in a commercial delay?

[Hoskuld]

Couldn't get past point 1: what do you think the "traditional approach" is?

[Joseph_K]

I'll add to this that my biostatistician friend (with over 30 years analyzing clinical trials for pharma and CROs) told me yesterday that it is common for the FDA to want a second P3 unless the first P3 was very strong.

I think the AA approach plus another P3 is great. (I don't care if Investor keeps wanting to characterize the P2b/3 as a P2 – I see it as a P2b/3 myself, but it just doesn't matter.) I see us marketing blarcamesine with Medicare coverage under this scenario since, unlike Biogen and Lilly, we aren't shrinking brains and making them bleed. What's not to like?

[Schmiggins]

Excellent. Thanks for the effort.