european approval, page-2

Hey Tewk;

European approval can't happen before December 2012 because of different laws there - but they can apply up to 2 years ahead of time so all the review work is done in advance of the opening day. That means they can submit the dossiers at the end of this year.

Reddy's will have to be involved at least in submitting the manufacturing sections which I guess are the biggest part. Don't know / can't remember if they get first dibs on sales - I seem to recall somewhere they have a right to negotiate but on't know where.

My understanding is that it will include ACS and all indications.

spacejunk