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Message: Sick Patients for Trial Design ... BETonMACE

Stock2740 wrote "I'm leaning to 18 month trial as sick patients increases Mace occurrence (sad but true the sick are helping our drug get to market )"

Not much of a stretch there, eh Stock? At least give credit where credit is due.

Anyone who watched the 9/25/15 corporate update heard Michael Sweeney and Kausik Ray explain that BETonMACE is modeled very similar to the EXAMINE trial, in which the 3-point MACE event rate in their patients was right around 10.5% at 18 months. BETonMACE is an event driven trial, with a goal of 250 events and a minimum of 2400 patients. 10.5% X 2400 patients gives you your 250 events at 18 months. Granted, the RVX-208 treatement arms are expected to have lower event rates. But as Michael Sweeney and Kausik Ray pointed out, BETonMACE will additionally have a low HDL (<45 mg/dL female, <40 mg/dl male) requirement that was not there for EXAMINE, so the average event rate for BETonMACE should actually be higher.

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