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MinnieM

12/11/17 1:29 PM

#207381 RE: slcimmuno #207376

As a patient, I'd be clamoring for Brilacidin as a potential preventative of severe OM.

Oddly, it seems that the incidence of OM in the placebo group was a bit low.

http://www.sciencedirect.com/science/article/pii/S0168165616315668#bib0025

Severe OM (SOM) occurs in almost 75% of these patients and is among the most debilitating and painful side effects related to treatment (Elting et al., 2009). SOM is associated with increased opioid use, weight loss, reliance on supplemental feeding and hydration, breaks in treatment, unplanned office, or emergency room visits and frequent hospitalizations resulting in an incremental cost of $18,000 per patient (Nonzee et al., 2008).



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petemantx

12/11/17 2:07 PM

#207387 RE: slcimmuno #207376

Are P3 trials normally open labeled or will we have to go thru the placebo arm again?