Anavex Life Sciences Corp (AVXL)

[TTTav66]

A bit of dd that may add to the speculation of planned timing to commercialization:

Rocio Garcia Canamaq, the founder of Leon Research—Anavex’s CRO for the phase 2 PDD trial in Spain—has been hired to be Anavex’s QPPV as of January per her LinkedIn profile. What’s a QPPV? From Wikipedia:

In the European Union, the Qualified Person Responsible For Pharmacovigilance (QPPV) is an individual, usually an employee of a pharmaceutical company, who is personally responsible for the safety of the human pharmaceutical products marketed by that company in the EU. This function was established in 2004 by article 23 of regulation (EC) No 726/2004. The article establishes that the holder of a marketing authorization for a drug for human use must have a QPPV. When a company submits an application for permission to bring a medicinal product onto the market, the company submits a description of its system for monitoring the safety of the product in actual use (a pharmacovigilance system) and proof that the services of a QPPV are in place.

This role is not related to the running of clinical trials. In fact:

If a company does not yet have an MA or a submission and is just doing clinical trials there is no requirement for a QPPV. This is a point that is not always understood. (From this article: https://www.c3isolutions.com/…/the-qualified-person-for-ph…/ )

I believe this move indicates that Anavex is actively taking the steps necessary to eventually file for marketing authorization with the EMA. Speculation here, but I believe that if the data is strong, they are planning to take this step after the currently running phase 2 PDD trial. Dr. Missling alluded to this at the ASM, but I believe this to be a tangible indicator of that goal. The new manufacturing information perhaps now adds to this case.

It is also meaningful to me that Ms. Canamaq, the founder of Leon Research, has taken on this role for Anavex. From the article referenced above:

The QPPV is a major responsibility that all MAH’s in the EU must fulfill and fulfill well. This is not a routine job but one that must be done well. Although safety issues may arise less in smaller or generic companies, the potential for a safety issue (or safety crisis) always exists and it is at these times that the QP becomes an important player. Similarly, during government inspections the QPPV will also play a major role. Thus the QP should be sufficiently senior, have authority, responsibility and the appropriate “power”. Although not necessarily a physician, it is wise that the QP have some level of medical training and experience. It is an important job and should be so treated.

This is currently a part time gig for her, but will be a crucial one for the company. Note, as of January, she has also taken on this role for a Spain based, privately held company, that has 3 clinical programs finishing up phase 3 trials and a publicly disclosed roadmap for their upcoming regulatory submissions in 2019.

Regardless if my interpretation here is right on the timing, this is an important and necessary hiring for any company that hopes to gain marketing approval in Europe.