RE:RE:New presentation uploaded
And what does line 8 mean?? No new agent for BCG refractory/relapsing non-muscle invasive bladder cancer since 1998 (Valstar) Limited late-stage competition Significant global BCG shortage FDA/AUA Bladder Cancer Workshop (May 2013) Enormous unmet medical need for patients who have failed BCG treatment Confirmation that single-arm trial design appropriate for BCG failure patients (no suitable comparable) Future guidelines in discussion. Has to refer to FDA.