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Re: To infinity and beyond! post# 241350

Monday, 09/17/2018 1:42:07 PM

Monday, September 17, 2018 1:42:07 PM

Post# of 403769
Hi TIAB, maybe delay was because IPIX waited to get more details about Galera's GC4419. It is much better to go to FDA meeting with solid comparative data (same applies, BTW, for BTD application). Galera presentation in June 28-30 2018 at Vienna provided enough (swimlanes - thank you very much for them) for reasonable comparison - something that any semi-capable competitive intelligence analyst at big pharma is able to perform in few days. I managed the same in slightly longer time and then forgot the whole thing.

But because you keep insisting I dug the stuff from my hard drive. Here are the highlights without much explanation. Sure the international pharma negotiating with IPIX has done something very similar and better; some of big pharma Co:s probably do have access to GALERA's patient level data. Novartis and Novo Nordisk for sure, due their generous funding of Galera.

First image is comparison between Galera's 'evaluables' for GC4419 vs IPIX's 'mITT' for Brilacidin. Probably the fairest active treatment comparison one can create based on available data. Kaplan curve for GC4419 is created from data that matches Galera's reported SOM median for GC4419, which Galera DID calculated using 'evaluables'.



Second image is for placebos in both trials. It should give one an idea how level this particular playing field is. A bit harder comparison to create due Galera's exclusion of about 10 SOM subjects with swimlanes from their median calculation. After some experimenting I came to conclusion that the curves have practically identical medians regardless how I selected Galera's placebo data or where I put those 3 additional SOM subjects not included in IPIX kaplan meier curves for PP population. Enjoy.








"I would rather have questions that can't be answered than answers that can't be questioned." Richard P. Feynman