RE:RE:Valstar Clinical Trial: 98% of Patients Were White!!!txb, within your letter you may want to also include the following:
1) An FDA panel in 2013 laid out a recommended clinical trial design. They couldn't come up with a concensus as to what should be used in the control arm (since the only thing available is Valstar and doctors hate prescribing it). Also, the agreed that a single-arm trial would be appropriate if certain long term cure rates were met (which MCNA met!)
2) Also, besides speaking about racial composition of the trial for an hour, the panel also spoke about not being able to approve MCNA "just because there is nothing else available," and they mentioned Gemcitibine being in phase II trial and being a viable alternative. IN THE SETTING THE MCNA IS TRYING TO ENTER, GEMCITABINE PERFORMED WORSE THAN A PLACEBO. Please look up the trial results if you don't believe it. I feel that the Adcom was polluted into thinking tangible alternatives to MCNA are readily coming to market.