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Message: More Than Just DSMB Green Light

"We know nothing solid about efficacy, but it does seem to be taking longer than expected to get MACEs."

Noretreat, we can't say that it is taking longer than expected to accumulate MACE. I'm assuming that you are referring to the time to achieve 125 events, or 50% of the original 250 MACE event target. All that has been disclosed (in the latest MD&A released mid-September 2017) is that the futility analysis will no longer occur at 50% of events but instead somewhere between 50% and 75% of events.

They may or may not have already acheived 125 events. In the early stages of the trial, we heard H1 2017, mid-2017 and H2 2017 used as projected estimates for hitting 125 events. My original estimate was Sept 2017. So if they have already hit 125 events, then the futility analysis is still on schedule. However, since most MACE events will occur in the first several months after each patient starts dosing, the delay in full recruitment will likely slow the pace of MACE event accumulation from here on out and delay the original estimated time to get to 250 events. 

BearDownAZ

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