I assume getting Orphan status lowers the bar for approval? Anyone know the stats on % of Orphan PIII drugs that get approved vs non-Orphan PIII drugs?
I own ALTH, which got FDA approval for their Orphan drug and the FDA panel discussion seemed to take this into account in their final vote eventhough the drug was not a home run. Seems to me that if GNVC's drug shows any kind of benefit it will go the same route as ALTH.
Kaplan is right. However, a major benefit to GenVec from orphan status is that 7-year exclusivity leverages potential partners' assessments of the risk-adjusted revenue stream from TNFerade for PC. This is a positive, obviously, and should enhance the eventual partnership deal.