RE:RE:RE:RE:Thoughts on why our phase II targeted a 40% efficacy....
diwa, nice post it is a bullboard no more and no less..but this is what i keep going back to:
"- In the FDA briefing document the FDA discussed a CIS population with contraindication to or refusing cystectomy"
..IMO there was no pre-AdCom FDA briefing document price cratering of TST as this is where approval is based, Adcom got a head of steam going down the "rabbit hole" and couldn't stop. but IMO and based on my non-science background, those are not really restrictions in any real way as as best i know isn't surgery the preferred choice always for this population and you need to refuse surgery to even get BCG as front line. as long as patients are unfit (which seems common) or unwilling (which seems equally as common) and with informed consent MCNA is good to go.
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