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Lemoncat

12/31/18 5:51 PM

#253077 RE: loanranger #253076

Yes. There was something odd about the placebo rate in that arm of the trial. It had superior results even compared to GC4419 which received BTD. It was about 30% lower than in the other two trials.

SOM in subjects with cisplatin Q1W schedule in IPIX trial.
Brilacidin: 7 / 13 or 53.8 %
Placebo: 5 / 11 or 45.5 %
Note: surprisingly low SOM rate for placebo.

Galera got BTD for GC4419 based on efficacy also in cisplatin Q1W group:
GC4419: 22 / 46 or 47.8 %
placebo: 31 / 46 or 64.9 %

If we can just find out what those placebo pills were packed with we will have OM licked!

PlentyParanoid

01/01/19 11:45 AM

#253120 RE: loanranger #253076

An old pharma tradition: if possible do not spell out unfavorable data, only imply.

BTW: Soligenix did exactly same thing with dusquetide - reported numbers for cisplatin Q3W group and left calculating the results for really awful weekly cisplatin group to rare enterprising reader. And then they made things interesting by accidentally (????) publishing wrong head counts for cisplatin Q3W group. Thanks to ClinicalTrials.gov consistency checkers the correct head counts enabling calculation of the results for cisplatin Q1W group can be found there.

As you can see, IPIX bunch are just amateurs...they forgot to fudge headcounts.