The Nuedexta launch in the EU will entirely depend on if the CHMP recommends Nuedexta for PBA patients with MS, ALS, stroke, TMI, dementia, etc. The market is not big enough for just PBA in MS and ALS patients! If the later, Avanir would likely refill an application or appeal, etc. Will the CHMP follow the lead of the FDA? Stay tuned!
with the CHMP meeting next week, if avnr has not been asked for a face to face meeting, approval is 99% in the bag. At least that is my take on the research that I have done. Maybe IR can shed some light on this, not sure if this is the type of thing that would require avnr to do a press release if they were asked for a face to face meeting. They should be able to let us know what has transpired up until now