Replies to post #360818 on Innovation Pharmaceuticals Inc (IPIX)

[Lemoncat]

https://static1.squarespace.com/static/5715352e20c647639137f992/t/59c41c8ed2b857d4a753fa6b/1506024591539/Tew-CurrTopMedChem-2017-2017-review+with+Rick+Scott.pdf

There were no treatment-related serious adverse events (SAEs) or cardiovascular SAEs and blood pressure events were low in the 0.6 mg/kg single-dose regi-men, similar to or better than daptomycin, an antibiotic with no reported blood pressure effects.

You're playing with words to make a statement that is technically true but is conveying an idea that is false to most readers.

In the Phase 2B Brilacidin ABSSSI trial, the only association any SAEs had with Brilacidin are that some people who got the comparitor and some people who got Brilacidin had some SAEs.

It is the principal investigator's job to determine whether there is causation and the FDA will review those conclusions: "There were no treatment-related serious adverse events (SAEs)"

The sheer number of excess SAEs compared to the comparators constitute a serious signal in themselves.

The ostentatious adjectives make this statement very misleading to a casual reader. The 0.6mg/kg arm (the most successful one of all the Brilacdin arms and the Dapto arm) of the trial had three SAEs. There were three SAEs. A "sheer" and "excess" three SAEs and they were deemed unrelated to treatment.

Page 18 for reference:

https://static1.squarespace.com/static/5715352e20c647639137f992/t/583f8286d2b85731b8713a36/1480557192947/A-Randomized-Double-Blind-Study-Comparing-Single-Dose-and-Short-Course-Brilacidin-to-Daptomycin-in-the-Treatment-of-Acute-Bacterial-Skin-Skin-Structure-Infections-ABSSSI1.pdf

We really need more Pharmacovigilance on this board.

Go IPIX!

[Jhawker]

After all the trials B has been involved with they were given fast track for covid and then were allowed to expand their dosing from 3 days to 5 days! Yes that means that the fda had no safety concerns at that point. “ IPIX) none of these SAEs were caused by brilacidin” couldn’t say it better myself!