Anavex Life Sciences Corp (AVXL)

[frrol]

Great post. You're pretty familiar with the guidelines and dates. So asking for eligibility is first step, submitting LOI second step, and CHMP appointment of the rapporteurs third step, which Missling said we're waiting on. You're saying it's the "second gating factor" but I think it's the third. From Missling it sounds like we've submitted our LOI, and the CHMP was still appointing our rapporteur(s) back in March.

https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/obtaining-eu-marketing-authorisation-step-step

I hear what you're saying about the rapps, because the guideline below says "The (co-)rapporteurs appointment procedure takes one month...". But it's after the LOI submission, because the LOI is an annex to the pre-submission request for rapporteur appointments according to Section 2.4.1.1:

https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/pre-authorisation-guidance

But the link above is a little confusing, because it says "This notification is also called the 'letter of intent'."

So yes our LOI filing is probably after the Dec 19th PR. I think from all the above, it's safe to say that around Sept MAA submission is likely.