Anavex Life Sciences Corp (AVXL)

[sokol]

This may explain why it is taking so long to start phase 3 for AVXL 2-73. This is from the article you referenced:

''Problems can arise with randomization, drug supply, and the recruitment of patients when there are adaptive changes due to dose selection, sample-size increases, or population enrichment. It is critical to ensure that the sample size at the interim analysis is adequate for making the adaptive decision. If patients are enrolled too rapidly relative to the time needed to observe the primary end point, the planned enrollment might be completed before adequate information is available for an adaptive decision to be taken. To date, regulatory agencies have opined favorably about adaptive designs.

FUTURE OF ADAPTIVE TRIALS
More widespread use of adaptive trial designs could accelerate the discovery process, especially if coupled with other evolving trial concepts, such as large, simple trials. Advances in adaptive trial design will require further dissemination and acceptance of the sometimes complex statistical methods. There is an intuitive appeal of adaptive trial design and its attempt to identify the patients who are most likely to derive benefit from a therapy, and this feature will resonate well with most doctors and patients."

It takes time to "attempt to identify the patients who are most likely to derive benefit from a therapy''. However, identifying patients that will benefit is key to regulatory approval of a drug for those patients, and I can see how this resonates well with doctors and patients.

People have negatively speculated about the delay in the announcement of the start of phase three -- about it taking so long, but this article gives a possibly rational explanation why it takes time and planning to do an adapative design. However, the time and planning increases the odds that the drug will be approved. Once approved, the drug will be used for all Alzheimer's patients becuase presently there is no effective treatment for Alzheimer's. All of this is consistent with what Missling has said about adapative designs.

See this: http://www.nejm.org/doi/full/10.1056/NEJMra1510061#t=article