RE:RE:the wag
dave, if i know correctly sugery (cystectomy) is the recommended treatment above any other treatment at every step of the way... doctors prefer it to BCG, to MCNA to ????, except in patients who are unfit for surgery..it is the patients who refuse surgery and ask for BCG, MCNA, chemo, etc. and EOD as id'ed in AdCom so long as the "surgery as the last resort" timeline (did i hear about 2 years) is not violated it is approvable... in fact in BMRN's slap down yesterday this was one of the key FDA reasons for likely rejection of their DMD drug, it actually shortened the nature progression to death that untreated boys faced...MCNA fits within the 2 years (i believe they stated that MCNA can be determined to be working by 6 months)
..so EOD adding the "surgery unwilling or unable" changes nothing in reality...Question is does the FDA buy it (the wordsmithing approach)??? lets hope so