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Message: Re: The waiting game.....
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Feb 12, 2019 05:09PM

It is totally believable that at peak enrollment, especially in the time of a lot of patients in the first 9 months of dosing, that 10-15 MACE events were accumulating per month. However, enrollment stopped ~11 months ago (not counting the last handful of China patients), which means all patients are now outside of the "riskiest" zone of experiencing a subsequent MACE event. Therefore, with enrollment being done and patients being outside of the hot zone, this MACE occurrence rate will fall. This is a phenomenon independent of the apabetalone effect that would influence the overall MACE occurrence rate going forward.

Recently we discussed how patient discontinuations/drop outs may be affecting things like patient year accumulation and MACE accumulation. It is reasonable to expect that ~25% of patients (including both apabetalone and placebo) will discontinue at some point in the trial.  These patients don't get "replaced" so as more drop out, the less patients there are to contribute to patient year accumulation. We really have no idea how many patient years there are right now. The less patients and the lower the patient year accumulation per month, the less events per month one would expect.

Although it is sexy to paint a picture that the longer the trial goes the better it is for apabetalone, this view does not account for the slowing of the trial due to the above mentioned factors.

BearDownAZ

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