Anavex Life Sciences Corp (AVXL)

[frrol]

The ethical challenges are avoided. Anavex is likely beginning the initial preparation for a phase 3 RCT very soon. That includes signing a CRO, trial design, and site selection. Enrollment will then follow. But dosing will not commence. That waits.

If the FDA agrees to consider 2-73 for AA, it will form an AD advisory panel, who will be given a package on 2-73 including pre-clinical and clinical results, as well as S1 research. After the panel's recommendation is given, the FDA will decide on whether to grant AA.

Once that decision is made, we begin dosing. How we dose depends on the decision.
If the FDA decided no for AA, our trial proceeds as a phase 3 RCT (ie, with placebo). If it says yes, our trial becomes a phase 4 with no placebo arm (ie, all receive the drug).

It is very difficult to do phase 4's due to the "time inconsistency" problem when a drug is approved under AA: the incentive to participate in a trial evaporates. This is why the completion rate of phase 4's are historically low. (Not because of 'greedy BP screwing everyone'.) It's also why the FDA is now effectively requiring that a confirmatory trial be enrolling before granting AA. And they prefer it to be fully enrolled. This doesn't eliminate the problem, just lessens it. The sponsor makes a best-effort to complete it.