InvestorsHub Logo
icon url

KMBJN

01/04/18 4:36 PM

#211529 RE: PlentyParanoid #211475

Thanks again for sharing your knowledge/experience with censoring, even if that means we figure it out together. You are way ahead of us lay people here who don't have much experience with the statistical methods used.

Not that it matters too much, but it looks like IPIX is using different definition of ITT for the B-OM study, as they reported 46 in the (modified) ITT group, out of 61 randomized, further winnowed to 39 in the PP group, further censored.

"In this trial, Head and Neck Cancer patients self-administered Brilacidin (45 mg/15 ml oral rinse—“swish and spit”) or placebo three times daily across 7 consecutive weeks (49 days). Of the 61 patients randomized, 46 patients met the cumulative radiation dose criteria of at least 55 Gy—the minimum treatment threshold for inclusion in the efficacy population—and 39 of these patients met more strict criteria for inclusion in the “per protocol” study population."

"Modified Intent to Treat (mITT) Population (n=46)
Brilacidin 9 of 21 patients (42.9 %)
Placebo 15 of 25 patients (60.0%)

Per Protocol (PP) Population (n=39)
Brilacidin 7 of 19 patients (36.8%)
Placebo 12 of 20 patients (60.0%)"

It gets confusing about who is called a dropout, why was a subject censored, who is excluded from one group and why, and all that.

As you said, it's probably enough for now :)

There are many nuances, but the results were pretty good (with somewhat small sample size) and a BP partner would be wise to jump on the big opportunity.