Replies to post #221437 on Anavex Life Sciences Corp (AVXL)

[nidan7500]

I am proud of how well Anavex has managed it's burn rate. It is an
case study on how to flip the system. Good job Dr M and C suite.

The context for CNS trials presents a slippery slope. I think we could argue that trials really should not be used to evaluate a large population of patients if the thesis they trying to prove is weak. This method of proof is flawed when used for that purpose. IMO, that is just weak clinical practice and cruel.

Dr.M. has said (and I agree) that PII is where the rubber meets the road. PIII must not be used as the sole stage to prove efficacy (you must already have proof of that), if we fail in PIII it is b/c we do not do a adequate job in pre-clinical evaluations. So far, Our clinical and trials work has been based on this premise, unlike many other sponsors who rely on PIII. Others do not get that.

IMO, this PIII practice in trials which has resulted in such extensive time lines and large samples. (big samples w/low pre clinical evidence) explain our differences from the herd where large samples for long time are a form of risk mitigation. IMO, we have also set higher end points in PIII for ourselves. This may not be obvious but I think that is what is going on here. Many trials have sloppy or weak PI,PII standings and try to power it through in PIII, leads to a lot of trauma and trap door failures for BIO-WS.

Bottom line, this has been our precision medicine strategy since day 1. Shorter or smaller PIII will work OK and the trial system in Aussies TGA is compatible with the whole thing. They get it, and BTW they rigorously control the trial environment and clinicals during PII/PIII which improves over all likelihood of consistent results.