Anavex Life Sciences Corp (AVXL)

[TTTav66]

The Phase 2 study commenced in October 2018 and will involve approximately 120 patients, randomized 1:1:1 to two different ANAVEX ® 2-73 doses or placebo, in up to 24 clinical study sites.

It is interesting to note that Dr. Missling stated on the call that they reached 100% site activation with 20 clinical trial sites.

On the clinical trial registry site, 22 sites are identified, with 20 being shown as active. This is consistent with the 100% activation milestone shared earlier. So, the company had a plan to potentially activate 24 sites if needed, and had reported 22 identified sites, but were able to declare full activation at 20.

On the topic of determining the number of sites needed; from the previously referenced article, Site Activation: The Key to More Efficient Clinical Trials:

Though the two activities are entirely different in content, patient recruitment generally occurs simultaneously with site activation. This is partly because clinical trial teams are often not sure they have an adequate number of sites until they come very close to their enrollment target. As a result, they tend to keep activating sites until enrollment is almost complete. Inevitably, recruiting at some sites is shut down within a matter of days, creating ill will and frustration

I'm left wondering, how close has Anavex actually come to reaching the 120 patient recruitment target if they were able to confidently stop activations at 20 sites? It's also worth noting that the last site activation date is listed as September 23rd, although the registration site was only updated with this info within the past few weeks.

On time to full recruitment, from the same article as above:

Here’s the truth of the matter: Enrollment cycle time varies by sponsor and disease state, but across disease states, site activation accounts for about 70 percent of enrollment cycle time. Given the near-perfect linear relationship between the two, we can conclude that patient enrollment cycle time is driven by site activation activities.

I'm looking forward to the promised, near future update of enrollment information. Should be interesting.