RE:RE:yankee- you make a good point
RG, you are correct; prescribing therapies/medication/MCNA off-label will happen and its legal. Some institutions do not let certain medications be prescribed off-label such as medications for chronic pain. When I was getting treatment at Brooke Army Medical Center; they started enforcing only label use for chronic pain medications, which wasn't to the satisfaction of doctors who worked in the Pain Mgmt Clinic. Since the MCNA BLA and specifically the Phase 3 trail was/is for second line(refractory) therapy, they had to go with the lower patient numbers which at any rate seemed to low for Orphan Status. When bladder cancer patients do their own research, they will demand MCNA as their first line therapy; its will be the future 'Gold Standard'. Anyone here who hasn't read the Trail results and is negative on the treatment an/or future pending approval has an agenda here; they know who they are. My only fear would some type of a CRL in regards to the manufacturing process/facility, which usually are easily correctable but a time setback; their mock audit is a great idea by the new team at Telesta. GL serious longs...keep adding