Anavex Life Sciences Corp (AVXL)

[Hoskuld]

90% of MAA applications would see a recommendation offered in November (all or nearly all in the Anavex cohort certainly will.)

The EMA is is a bureaucracy. 60 people, 2 from each country, will vote on the blarcasermine recommendation. They vote based on their rules and rubrics. Yes, there is some discretion, but not too much. No one individual is going to have much sway - probably the majority of people have no strong opinion about Gabelle or Sabbagh. I bet quite a few don't even know who they are. Likewise, no one know about Kun Jin. They do know their process and tradition. The notion that a confirmatory trial is unneeded or that economic considerations will sway the committeee...these notions are wrong. The idea that an OLE is a confirmatory trial is also wrong. No one on the CHMP committee is drinking the koolaid here.

But, the data is outstanding for what it is. And the GWAS supplemental data is excellent, too. We have to hope that enough CHMP members are persuaded by the data and analysis so as to override the confirmatory trial concerns.

Steady wrote that running a confirmatory trial makes no sense because maybe it won't confirm the original findings. He meant it as some sort of logical dunk on me - but in fact it is exactly what the committee will be concerned with: did they not run a 2nd trial because they thought the data would not confirm the original trial's findings?