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baytdr

12/15/17 4:09 PM

#208446 RE: Jhawker #208443

the upcoming conference may offer substantial color regarding these points of interest.

frrol

12/15/17 5:49 PM

#208453 RE: Jhawker #208443

A couple things: The placebo numbers have no effect on the drugged numbers, and the "outlook" is another issue. What is implicit in your "outlook" statement is actually let's ignore or handicap the low placebo number in the post-interim cohort. The drugged arm was poorer in the post-interim cohorts compared to interim. But they are all under the same trial conditions, and the trial was sound. You must consider all results. The FDA and BP do, rightly so. As you increase sample size you tend toward "real effect", not away. Statistically and logically, ceterus paribus with same trial conditions in both arms, don't expect nice surprises. A nice surprise is not impossible, just not likely.

Most likely: the shortened duration of OM with B was good too (not spectacular), which would be good. Good results are enough. I hope for spectacular, but not counting on it.

To infinity and beyond!

12/16/17 9:30 AM

#208511 RE: Jhawker #208443

this of course assumes that those getting B OM would keep their reduced rate of stage 3 mucositis and the placebo group would do worse. Why? It is just as likely that the treatment group would have more severe mucositis too