Replies to post #122612 on Anavex Life Sciences Corp (AVXL)

[Investor2014]

Further to this regarding A2-73, my guess is that a "Basket Trial" could be in play.

A basket trial (bottom) involves multiple diseases or histologic features (i.e., in cancer). After participants are screened for the presence of a target, target-positive participants are entered into the trial; as a result, the trial may involve many different diseases or histologic features. A master protocol for a basket trial could contain multiple strata that test various biomarker–drug pairs. Statistical approaches are not depicted in this figure.

Thinking of Ariana, perhaps the time is going into identifying a target and target-positive participants across specific endpoints applicable across say PD and AD, but perhaps not Rett, which I suspect will be executed standalone.

[XenaLives]

That article was dated July 6. It pretty well defines what the FDA is looking for in trials, so I believe we can say that Anavex had clear guidance from the FDA at that time, probably from the moment that Fadiran came on board.

I believe that Missling will roll out at least three trials by end of year. INDs have already been filed and will soon be announced.

http://www.nejm.org/doi/full/10.1056/NEJMra1510062#t=article

[Talon38]

Investor, The Master Protocol concept of drug development seems to be a a very real step forward for those suffering from diseases as it increases efficiency and effectiveness of precision medicine. The drug companies may be less inclined toward the collaborative management of trials though. However, it looks like is already in place for breast cancer and some lung disease. CNS disease would be the logical candidate for the next FDA Master Protocol. We would be in that transition phase and how that would effect our P3 for Alzheimer's is anybodies guess. If our in-house P3 was successful, the FDA might build the Alzheimer's Master Protocol around a 2-73 SOC. It will be quantum leap for precision medicine but it will take time.

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From the paper

"Taken together, stakeholder coordination, infrastructure requirements, and complex trial-design elements can extend the start-up time for a master protocol considerably, as compared with that for a single-purpose trial."