Replies to post #506510 on Anavex Life Sciences Corp (AVXL)

[hnbadger1]

That surprises me as the ADL endpoint is supposed required endpoint for the EU.

Factanonverba Nov. 10 at 7:22 AM
"$AVXL Just got a call with Clint. It's an in person meeting in Amsterdam, Chris will be present. It's primarily about unsolved questions (ADL end-point).
The question is, is that a really relevant end-point and is all supportive new information that came up in the past months good enough to swallow that missed point.
He believes it does. We are not dealing with Cassava like people. These are thorough scientific seniors who worked years to achieve tomorrows meeting and the rest. It will be a very binary week however I think.
Success to all longs."

[D-Mike]

My gut says if that was an issue it would have been identified during previous clock stop?

[ExtremelyBullishZig]

Of course the company rep thinks they have it covered! I think I brought up the ADL issue a couple times, but I just kept being told that it doesn't matter. Apparently it matters to the EMA and the CHMP...

[attilathehunt]

It's an in person meeting in Amsterdam, Chris will be present.

OH Fxxx!!! My worse nightmare just came through!

[rx7171]

So is the slightly missed ADL during the 48 weeks countered successfully by the highly statistically met ADL in the OLE?

Knowing ADL sensitivity in a short early Alzheimers trial has become recognized as problematic the data from a longer trial period should take precedence.

The question however is will the OLE data be given the same degree of credibility as the 48 week trial data since it is unblinded and subject to placebo effect?
Due to the total trial length including the OLE I believe the positive ADL data will be accepted as an accurate reflection of a true disease modifying effect.