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Message: Resverlogix Announces Publication on Apabetalone in Clinical Epigenetics

"Gran Oso does the FDA consider the combined results of the same group of patients between two trials? In this case phase 2 and 3"

I'm assuming that you are referring to the FDA considering combined MACE results. As one can see in the Atherosclerosis 2016 paper there were very few 3-point MACE events (8 total) in the combined SUSTAIN and ASSURE trials (presumably all deaths and non-fatal MI since non-fatal stroke was not listed). Most of the MACE observed in the Phase 2's were of the non-3-point MACE variety. So I personally don't see much usefulness in combining a small number of 3-point MACE results from the Phase 2s with those from Phase 3 BETonMACE, which will have >250 3-point MACE events. As for the FDA, I don't think MACE data from the Phase 2s is going to influence them one bit in my opinion. It would obviously be best if BETonMACE succeeds on its own merit and doesn't require any data-bending to support apabetalone having a MACE-reducing effect.

BearDownAZ

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