Anavex Life Sciences Corp (AVXL)

[nidan7500]

But biomarkers are not the same as symptoms, so the risk is that costly new drugs will be approved that do not actually work.

He is right on, IMO. Translates to: We (ME&FDA staff) do not know if we are going to spend a lot of money and time and get nothing for it .(Like BP has for the last 40 years w/FDA guidance) We just cannot go through another 30 years of telling people we cannot help them. There is no treatment.

Therefore, FDA are going to use the Cancer Treatments model/methodologies and will map-follow progress very closely. We do not know what will work and what will not work but expect that RWE and clinical testing should(quickly) tell us if we are on the right path. We think this human based instinctive model will/should at least provide feedback we can use real time.

A2-73 should provide quick feedback on efficacy of treatments. It may not be a "one size fits all" molecule but the process of measuring and adjusting is known to work. Sample size and statistical rationale will still be involved as protocol but they will be used in different ways than in the past. There are a lot of moving parts and not everyone is on the same page yet. We do not expect 100% failure with A2-73 like in the past AD trials, for which many are still in denial. We have still not figured out who to fault for all of that. Wouldn't it be nice if we could just start doing our new trials and not tell anyone yet.

Now, just do it.