"Since the AGM we have been given guidance that the top line would be delivered in H1. If you are expecting 250 events by Feb 12th after an updated guidance has been given for H1, are you setting yourself up for future frustration? H1 begins in April, lm not expecting top line until then. If it comes sooner, Yahoo."

First off, H1 begins January 1 and ends June 30. Feb 12th lies in both Q1 and H1. Q2 begins in April. April lies in both Q2 and H1. Q1 and Q2 are both part of H1. Who's on first?

Second, I am not expecting top-line by Feb 12th. I never said that. Reaching 250 adjudicated events and ending dosing is not the same as releasing top-line data. I have been digging at nailing down when 250 adjudicated events would be reached, because this not only triggers end of dosing but also requires material disclosure.

Third, good time for a reminder of the order of events. 

1) 250 adjudicated events achieved, triggering end of dosing.

2a) Completion of adjudication to evaluate remaining unconfirmed events and possibly move more into the confirmed/adjudicated category. 

2b) Last patient follow up safety visits.

3) Database lock (might occur prior to completion of 2a and/or 2b)

4) Crunching and analyzing the data

5) Top-line data release for primary outcome (possibly CKD and cognition sub-study results too if available).

6) More crunching and analyzing the data

7) Full primary outcome data presented and published

8) CKD and cognition sub-study results reported if not done earlier

8) More data analysis

9) Pre-specified comparisons for primary outcome reported

BearDownAZ