MYOK - Finally read the data PR and CC transcript. Not sure where to start. I guess I wasn't the only one confused by trial protocol as written on FDA website and what actually occurred with cohort B. So was that just a change that wasn't updated or perhaps it is considered not important enough to update. I think given the side effects of bb's, ace inhibitors, calcium channel blockers that it is important to have it separated out in the first place. Some clarification from the company would be helpful. My other thoughts relate to how they define oHCM in the inclusion criteria and stabilised optimal medical therapy of patients prior to entry.
From data PR >>>>
in Cohort B, all of whom completed the study. Nine of ten patients remained on background beta blockers.
Reading the Q&A with CMO. He confirms cohort B patients were on beta blockers.
From FDA Pioneer HCM >>>>
Part A: Ongoing therapy with beta blockers, calcium channel blockers, or disopyramide. Subjects on any of these medications who, in the opinion of the investigator, can safely be withdrawn are eligible as long as medication is discontinued at least 14 days prior to the Screening visit.
Part B: Ongoing therapy with calcium channel blockers or disopyramide. Subjects on any of these medications who, in the opinion of the investigator, can safely be withdrawn are eligible as long as medication is discontinued at least 14 days prior to the Screening visit.
