Abe: Yes, that would be great! Happy Thanksgiving to you! I'm just about caught up now and happy my ortho doc gave me something to help me carry out today's family gathering at my eldest daughter's (and her whole family...son-in-law & daughter)....glad my other daughter is bringing us out to visit them with her two daughters....so glad that our 3 grandkids are all home for Thanksgiving from college, I should be in much better spirits now!
I was hoping to get your opinion on the recent PR. Pretty impressive, aye?
I guess you missed my post. I had already offered my opinion a couple hours after the PR in post # 439367
Anavex PR'd that they sent in a request to the EMA asking permission to send in one type of MAA application instead of the default type. There's nothing negative but nothing earth shattering positive either. All biologics and most new drugs that turn in the MAA go through the Centralised Protocol. This is not a material event (try to find another company that PR'd this common event). I would be shocked if the EMA does not honor the request as they do with most drugs. What happens if Anavex receives permission to use the Centralised Protocol and then does not turn in an MAA? Nothing, they can re-apply in a year. And reapply again a year later. And reapply again a year after that... The renewable basis is certainly a positive for Missling. From the guidance "Conditional marketing authorisations will be valid for one year, on a renewable basis. The holder will be required to complete ongoing studies or to conduct new studies (as part of specific obligations) with a view to confirming that the risk-benefit balance is favourable. "
I'll be a little impressed if an MAA is accepted and a lot impressed if the MAA is approved
Off to make the cranberry sauce for the meal - Have a Great Thanksgiving!
News 
Market Data 
Discover 
