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Message: Re: The countdown to 250
5
Oct 10, 2018 12:35PM
3
Oct 10, 2018 03:43PM

Tada,

I took another listen to the webcast of the AGM. Slide 17 (~minutes 18 to 23) pretty clearly lays things out, IMO. DM expects to hit 250 events close to year end at which time dosing will stop, the multi-week safety follow up will occur, and adjudication will be completed.

But I see what you are saying. Perhaps when DM said they are right around 200 accumulated events (note, he never said 200 adjudicated events), that maybe these numbers were a few weeks old. So maybe they were closer to 210-215 than 200 at the time of the AGM. Taking that ambiguity into account, perhaps the expected range to hit 250 and stop dosing is Dec 1 to Dec 31. 

You also wrote "We were also told at the AGM that recruiting continued in China until June. Will we have to wait until the last patient recruited reaches a minimum of 6 months in the trial before their numbers count?" Yes, DM stated that last China enrollment was towards end of June. So this last patient(s) should reach 6 month minimum dosing by end of December. What happens if 250 events are reached before the last China patient reaches 6 months of dosing? I don't know for sure. But I'm not expecting 250 until Dec 2018 anyway, at which time this patient should have met the 6 month minimum.

My current estimates are 250 events/end of dosing completed Dec 2018, safety follow ups/adjudication completed by Feb 2019, top-line data by Feb 2019, full CVOT data at American College Cardiology (ACC) March 16-18, 2019. Note: Late-Breaking Clinical Trial Submissions for ACC 2019 are open Wednesday, Oct. 24 – Wednesday, Dec. 5, 2018. I don't think BETonMACE has to be complete to submit for ACC Late-Breaking Clinical Trial.

Kind of a tight timeline for making the ACC presentation so quickly after top-line data. Not unprecedented. FOURIER/PCSK9 had top-line early Feb and full data at ACC mid March. And that was a much larger trial. If not ACC, lots of other conferences possible.

BearDownAZ

3
Oct 12, 2018 11:41AM
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