RE:ADCOM line
What about the part where they suggest MCNA is too safe ( going off memory here ) and would put the bar too high for other drugs to get approval if MCNA approved, WTF and F*CK ME! I heard right , right? Something was totally odd about this ADComm.
They totally ignored the fact also that MCNA met the AUA/FDA agreed upon guidelines for efficacy on the study. They couldn't get past the thought of a single arm study. This and the fact it is twice as good and way more safe than the only approved 2nd line drug Valrubicin/ Valstar ( or whatever it is ) , is grounds for a lawsuit if not approved. JMHO
This was far and away an unfair ADComm and the FDA knows it. Should have had an FDA official chair this thing to keep it on topic because the Chairman lost total control of this when specifically talking about the trial. This trial was OK by the FDA/AUA who spent a hell of a lot more time actually looking at it than the few minutes, if at all, by the committee!
GLTALongs
13PD