Re: Timelines
in response to
by
posted on
Aug 27, 2019 06:59AM
Paladin,
Thanks for bringing up the wording of the July 8th news release. As RVXoldtimer pointed out, there is ambiguity in the July 8th statement "Approximately two weeks after DBL – currently projected for within September 2019 – top-line results (i.e. primary and selected secondary endpoints) are expected to be announced." In addition to this statement, the July 8th news release states top-line results are expected September 2019. Then there is the Third Eye loan statements involving the Sept 16 date.
Together, I interpret this to mean that top-line could come: 1) this week (some wiggle room with the begining of September) or early next week, with database lock ~2 weeks prior (already happened); 2) end of Sept to early October (some wiggle room with end of September), with database lock around mid-September; 3) by Sept 16th to satisfy the Third Eye loan, keeping in mind that the loan maturity date could likely again be extended. In this third situation, database lock could happend anyday now. So because of the ambiguity, we should expect top-line data anyday now in the next 5 weeks.
As for what secondary endpoints will be in the top-line news release.....there are many secondary endpoints; the cognition and CKD sub-study are just two of the many secondary endpoints. If I recall, management has communicated that top-line for the cognition and CKD sub-studies will be included in the top-line data announcement for the primary MACE endpoint.....if available. So in my opinion they have given themselves wiggle room to include or not include whatever secondary endpoints they choose when they announce MACE top-line.
BearDownAZ