It is a FDA mandate to facilitate new drugs to the market that compassionately ease suffering and possibly be a life extender. Marqibo fits both categories it appears..and since it is a high test version of an already existing drug vincristine, Combined with a 7 to 4 in favor from ODAC, I think this looks pretty good Also , you dont say you are negotiating REMs with FDA, with a drug that isnt likely to move forward...