Anavex Life Sciences Corp (AVXL)

[gerry57]

I am not sure about sales and marketing being within the purview of an EMA application . Manufacturing is definitely part of it though. CMC(chemistry manufacturing control) and GMP(good manufacturing practices) are areas of high concern with both EMA and FDA in fact they collaborate on the requirements of these areas. I would add both have noticed problems with small biotechs getting their drug from lab production to commercial production. To wit: BCLI stating nurown production problems were minor while FDA publicly stated later they were serious (granted nurown is a biologic not a drug) it does not change the concern of the FDA or EMA though. Sales marketing and manufacturing do seem lumped together as a concern though, perhaps a strong partner allays those concerns all at once.