Replies to post #120879 on Anavex Life Sciences Corp (AVXL)

[kld2]

If Ariana came up empty then I'm sure the company will continue but simplified qualification criteria and fewer arms.

I do find it odd that we haven't heard anything from Ariana. In Missling's Noble presentation he reiterated the importance of the PK/PD analysis. What gives?

[makemydaze]

If Ariana is/was able to identify a trend using the data collected from the 32 Alz patients will that translate into identifying a subset of people that will benefit the most from 2-73 irregardless of their disease?

For example the following statement makes it seem (to me) that the 32 Alz patient data would assist in a Parkinsons trial also -

"Anavex’s 32-patient Alzheimer’s study utilizing KEM® will enable systematic analysis of more data on each patient in the disease group, on par with similar studies of significantly larger size, while providing greater cost and time efficiency."

“The ongoing Phase 2a Alzheimer’s clinical trial was specifically designed to learn as much as possible about ANAVEX 2-73 in order to optimize trial parameters for future pivotal trials and potentially reduce the risk of failure in a later, larger Phase 2/3 study and in a planned Parkinson’s Phase 2 study. We believe that the collaboration with Ariana Pharma will potentially accelerate the development process,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex.

http://www.arianapharma.com/2016/10/anavex-life-sciences-and-ariana-pharma-collaborate-to-accelerate-timelines-and-improve-efficiency-of-alzheimers-and-parkinsons-clinical-development-programs/

[Gernee20]

You don't know its proving difficult, Frrol. You actually have no idea. And, if we stick to what the company said, and keeps saying, they will start 3 trials by years end. If they are confident enough to keep reiterating the start of the 3 trials, I would say things are going according to a timeline that is still on track.

I wrote a post a week or so ago, which proposed what I thought was a very reasonable cause for delay of trial start. I will say again, it is very possible that the FDA in the new "master protocol" protocol, might require the trials to start within a certain timeframe of one another. Being endpoints will correlate within all 3 trials (assuming master protocol), it would make perfect sense that the trials run simultaneously to some degree. The whole point of a master protocol is to provide a quicker route to approval for a drug which is safe and has the potential to treat multiple indications. My take is in order to do this, trials should more less occurr at the same time. Not sure what you all think here, but if this is the case, Rett was probably put off for a few months until PK and AD were farther along in the planning stage.