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Message: Re: No ESC 2019 Late Breaker
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Jun 26, 2019 10:34AM

Iconoclast,

You did a great job summarizing a lot of the unknowns. As most on this board appreciate, I like to acknowledge all possiblities while taking into account uncertainties and unknowns. ESC full data presentation as a late breaker was one of those possibilities that we can now cross off of the list now that the late breaking presentations have been announced. It was never a given to present BETonMACE data at ESC, only a possibility. The ESC 2019 full data possibility was contigent on everything falling into place on the earlier side of things. For example, final patient safety follow ups completing July 4, database locking almost immediately, top-line data mid-July, ESC full data beginning of September.

Hindsight is always 20/20. Now that we know ESC 2019 for full data is seemingly out of play, this widens the bookends for full data timeline a bit. But top-line timeline hasn't changed as of now. 

Unknowns: 1) Duration of time to complete final patient safety follow ups (anticipated around July 4); 2) Duration of time after completing #1 to enter in all final data, clean up the database and answer any final quieries. Only when this is done with the database lock; 3) Duration of time after #2 to announce top-line data. Management has given 2 week guidance but that is not set in stone; 4) Duration of time after #3 to present full data. This is greatly influenced by the available events (i.e. ESC, EASD, AHA, etc.).

Database lock could happen as early as next week assuming the final patient safety follow ups conclude as anticipated on July 4th. The database probably will not lock immediately, in my opinion. But if it does, then following the 2-week post database lock for top-line guidance then we could theoretically still get top-line mid to late July. These are just possibilities. Not to be confused with likelihoods. In my opinion, top-line August is more likely than top-line July. Maybe even September for top-line? Management has indicated that they will communicate updated timeline for top-line data once the final patient safety follow ups are done. We will know more when we get that info. We might get that info next week.

BearDownAZ

 

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