ADCOM line I find this line from the ADCOM summary interesting. Vague diuscussion talks about MCNA possible being as effective as BCG but too similar in it's machanism? So working as well as BCG but much safer and available is not good enough?
"But in the absence of a control arm, several panelists noted that it was impossible to know whether those
outcomes in fact signified a clear improvement. There was also the issue that, like BCG, or Bacillus
Calmette-Guerin, the precise mechanism of action of MCNA is not known. It's not even clear, others pointed
out, whether MCNA works differently enough from BCG to warrant approval – or whether it relies on BCG to
prime the immune system or might prove handy in a first-line setting"