Contrarian ViewI have read a number of opinions on a number of sites and it seems most believe, and support in great detail, that every key aspect of MCNA, while not perfect would warrant an approval of some variety. The only contrary explanation I have seen, if this is an explanation, is essentially " no Adcomm Yes no approval". there has not been a single detailed sentence anywhere in cyberspace that has said the safety/ efficacy of MCNA does not fit within the parameters of AUA and FDA approve ability guidelines. Not one sentence but lots of "No Adcomm/No Approval" ? even the one gentlemen(DWD) from Seeking Alpha asked a litany of questions about everything but the colour of MCNA but no explanation of why safety and efficacy will not suffice That is very unusual and very telling. Somehow the FDA needs to present a summary of Adcomm findings without embarrassing many of the members who attended but showed little to no knowledge about single arm approvability guidelines in refractory BC. Is there precedent for this?