Innovation Pharmaceuticals Inc (IPIX)

[PlentyParanoid]

I was thinking more along the lines IPIX interpreting cumulative radiation dose to be below 55 Gy, which was the exclusion/inclusion limit for mITT. Then FDA saying that it looks like above 55 Gy. Or rejecting subjects because of other protocol violations and FDA not agreeing.

Head count ratios cisplatin Q1W/Q3W for Brilacidin and placebo seem to indicate that Brilacidin Q3W group was subject to more rejections than others. Still, it would take a good and unlikely number of FDA reversals involving SOM subjects to bring response rate in cisplatin Q3W group above that reported for dusquetide. Also, it is quite possible that IPIX did not stratify by cisplatin schedule, in which case my comment is moot.