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jshaffer85

10/09/07 9:39 AM

#813 RE: psych7 #812

re orBec(R) Clinical Summary Published

In the pivotal Phase 3 trial, among patients eligible for prednisone taper after 10 days of induction therapy, treatment with oral BDP reduces the risk of GVHD treatment failure at study days 50 and 80 by over 60%.

This is a very declarative statement and the first one from Dor in a PR that highlights the data with a guarantee period.

So close to PDUFA does this suggest the FDA has bought off on this analysis?