Well, it's not acceptable, presuming you are speaking of the incidence of MI on the high dose vs controls. Even though its a small number of MI's in a cohort of very sick patients, this will have to be addressed. Troponin levels, dose vs. control, did not suggest a dose dependent effect of the agent on heart failure, which is interesting, if not encouraging, supporting the thesis of the novel mechanism of OM's effects without increasing cardiac metabolism beyond the capability of these failing hearts.
I posted a few days ago that in an acute situation, if this effect WERE real, that is, increased MIs, it would not be the end... It would be a rough hurdle for CYTK and Amgen to leap, but it wouldnt be the end. Amiodarone, developed in the 60's and 70's was not FDA approved until the mid-80s. It's an anti-arrhythmic that decreases vfib, afib, and vtach, but its got a horrible side-effect profile, including MI, pulmonary toxicity, thyroid problems, and even cancer. But sometimes this is the best and only thing in dthese kinds of ifficult clinical cases. OM appears to be NOWHERE as dangerous as a novel and apparently effective solution to its indicated uses. That's not to say that a stronger understanding and profile of side effects is unimportant, or should be ignored by investors, but it does point a focus of the studies for the next few months/years. I believe it hopeful and, along with Tirasimtiv, a reason to follow and trade on the ups and down of this stock (and using profits to play with the "house's money") in anticipation of successfully commercializing OM.
Not significant. Not dose related. Quote from PR;
"Rates of adverse events (AEs), serious AEs, adjudicated deaths and hospitalizations were similar between omecamtiv mecarbil and placebo groups. There were seven post-randomization myocardial infarctions in the omecamtiv mecarbil treated groups compared with three in the placebo groups (2.3 percent vs. 1.0 percent, respectively). However, there was no relationship between the maximum increase from the baseline troponin (a biomarker specific for cardiac muscle damage) and increasing plasma concentrations of omecamtiv "
Also even though these patients only were treated for 48 hours they were followed much longer, 30 days I believe. Several of these MI's occurred long after treatment, where they would be no drug left in the system.