Replies to post #450982 on Anavex Life Sciences Corp (AVXL)

[Joseph_K]

I definitely do not see that sequence. Look, for example, at the sequence as presented here:
https://learning.eupati.eu/mod/book/tool/print/index.php?id=893&chapterid=822.

The Heading for the entire sequence is:

1. EU Regulatory procedures for a marketing authorisation (MA)
1.1. Centralised procedure

It makes no sense that there would be a request to apply for centralised procedure after the Submission of Eligibility Request has been approved: Centralised procedure is precisely what the EMA is agreeing to in response to the Submission of Eligibility Request. That's why the whole section is under "1.1. Centralised procedure." There is no "less ambitious request that could have been made." What could it be? What would that "less ambitious request" be doing in the section entitled "Centralised procedure"?

Additionally, note that the sequence does not include anything specifically about a "specific request for a centralised procedure." In fact, it does not list any submissions (applications) the drug company is to make between the Letter of Intent and the MAA.

Likewise, look at the EMA's own webpage, "Obtaining an EU marketing authorisation, step-by-step." https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/obtaining-eu-marketing-authorisation-step-step
You'll find confirmation of everything I said above.

[boi568]

I posted some time ago that a document on the NIH website describes a Letter of Intent as "triggering" a Centralised Procedure request. Here is the link, which is all about the EMA process:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3149704/

"The process of the centralized procedure is triggered when the applicant sends the letter announcing the intent to submit a MAA (letter of intent), which is usually done at least seven months prior to the targeted submission date."