>>Commercial Coverage PROvideTM-the PROVENGE Commercial Co-Pay Program that provides flexible coverage of up to $10,000 over 3 PROVENGE treatments. Eligibility is determined by Dendreon.
ORBIS requires an FDA submission and the review runs exact;y as it would w/o ORBIS. What ORBIS allows is for other RA,s to partake in the review and/or to use the review results to assist in their decisions.
As far as the rest of your post, running a P3 trial that failed badly between the arms as designed and trying to use post hoc ECAs (with non patient level data and unmatched trials) does not prove effectiveness.