Our best hope here is that the EMA is willing to have Anavex submit further biomarker data before the December vote. If that's what is happening, it may not change the outcome in December (although it might), but it would significantly improve the chances for a reversal upon a requested re-examination of a negative opinion.
We have two pieces of information -- relevant elements of the EMA re-examination procedures, and today's Anavex PR. They don't match up as closely as I would like.
First, the press release:
"The Company intends to request a re-examination of the CHMP opinion upon its formal adoption, including providing relevant biomarker data, based on feedback and continued guidance from the CHMP, EMA and the Alzheimer’s disease community."
Second, with thanks to HomelessEconomist for the link:
"The re-examination procedure may deal only with the points of the opinion initially identified by the applicant and may be based only on the scientific data
available when the Committee adopted the initial opinion."
Is the Anavex PR incorrectly assuming that the company can supplement its MAA with additional biomarker data subsequent to the December vote, or does it imply that it has received "feedback and continued guidance from the CHMP [and] EMA" that will allow it to submit "relevant biomarker data" before the December vote? I hope they mean the latter, because that appears to be the only avenue to get more information into the record.
It's also possible that Anavex may have requested the oral explanation in order to buy the extra time before the committee vote that would allow it to provide the most recent OLE/GWAS analyses, etc.
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