Replies to post #508131 on Anavex Life Sciences Corp (AVXL)

[WolfofMia]

Mayo they are allowed new analysis of existing collected data.

What is not allowed is newly collected data.

The data need to be submitted was already collected a while back.

This was just an analysis.

[Hoskuld]

https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/procedural-advice-re-examination-chmp-opinions_en.pdf

The applicant/MAH shall forward to the Agency the detailed grounds for the request for reexamination of the opinion. As stated in Article 62.1 paragraph 4 of Regulation 726/2004 and Article 32.4 paragraph 3 of Directive 2001/83/EC, as amended, “the re-examination procedure may deal only with the points of the opinion initially identified by the applicant/MAH and may be based only on the scientific data available when the Committee adopted the initial opinion.”

The above seems pretty definitive about whether new info can be brought to bear or not. How do you read this?

[Investor2014]

Surely CHMP must have considered the OLE as a KOL according to Missling told Anavex it can replace a confirmatory trial.

[ignatiusrielly35]

Wouldn't they have been able to present new data after the initial filing to specifically address concerns raised in the LOI?