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Message: The waiting game.....

KBC, I think NBB was just reiterating that IF Feb 12th comes to pass and there is no announcement about hitting 250 events, then we are left to wonder: 1) Was 250 events reached and no announcement made? or 2) Has 250 events not been reached meaning that the ACTUAL event rate was indeed less than 10 per month?

On that note, Snobei over on Stockhouse had  post titled "What they MIGHT disseminate" that touches on many facets of the current situation. 

"By your own assertion earlier, this might not mean that the rate has dropped below 10 per month. They may not give us top line but simply combine it with full data set and release together, sometime in the summer at a major conference. No? Did i misunderstand? I sure hope that this will NOT b the case as it would increase the wait without a material nr to appreciate the sp."

1) The MACE rate being 10-15 per month, or below 10 per month. This was covered above.

2) Is it material information for Resverlogix to disclose that 250 events have been reached, and if it is not material will Resverlogix choose to disclose this when it happens? Could 250 events and end of dosing already have happened?

3) End of dosing and hitting 250 unofficial MACE events is not the same as and is not the trigger for top-line data release. Those unofficial MACE events have to be adjudicated first, for which latest guidance was 2-3 months for adjudication of all events after end of dosing. So IF Resverlogix announces end of dosing/250 events, this starts the 2-3 month clock, IMO. As we touched on before, safety follow ups are another consideration in "completing" the trial, and the timing of safety follow ups/last patient visits may or may not influence the official trial "completion" that may be necessary before a green light for top-line data release.

4) As for foregoing top-line data announcement and presenting the whole enchilada of full data at a conference, really the only conference I see that happening at is at the March ACC 2019 conference. We'll know in less than 2 weeks if BETonMACE has an LBCT slot at ACC 2019. If not, then I 99% expect a top-line data announcement with minimal details to come first, followed at a later date by full data presentation at a major conference. The thinking here is that there is a big gap of 2+ months in scheduled conferences between ACC and the next wave in May/June. There is an ACC window of opportunity, which if passed the normal top-line followed by full data format is more likely.

BearDownAZ

 

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