Growacet, you are asking some great questions today. I started writing this draft post earlier in the week and just needed the right time to finish is and post it. Thanks for the set up. 

I took a look back at both the EXAMINE and REDUCE-IT trial timelines, paying extra attention to the end of dosing, last patient visits, and other milestone items related to adjudication, database locking and reporting of data.

EXAMINE was actually stopped early. EXAMINE was designed to test for both non-inferiority and superiorty. After an interim analysis at 550 events (target was 650), the findings "indicated noninferiority but not superiority of alogliptin to placebo, and the conditional power for superiority at 650 events was less than 20%; therefore, the data and safety monitoring committee recommended to the steering committee that the study be stopped. On March 9, 2013, the steering committee accepted the recommendation, and the sponsor agreed to stop enrollment in the study and proceed with a timely and orderly study closeout. The final date for evaluation of vital status was June 18, 2013."

So for EXAMINE, follow ups of the 5380 patients took about 3 months. There was no top-line data teaser for EXAMINE. EXAMINE full results were presented Sept. 2, 2013 at the ESC Congress 2013 in Amsterdam and simultaneously published in the New England Journal of Medicine. When did adjudication complete? I can't tell, but according to the trial listing there was an adjudication cut-off date of May 31, 2013, whatever that means. Could top-line data have come out before Sept 2nd if they wanted to go that route instead of full data at ESC? Probably. Although EXAMINE had over double the patients and over double the target MACE events as BETonMACE, it still provides a good example of needing a few months to close out a trial and analyze the data.

Another great contemporary CVOT trial example is Amarin's REDUCE-IT trial, which provides an example blue print of the type of news releases and timelines from a recent CVOT. They announced top-line data on September 24, 2018 and full data was presented in November 2018 at AHA. But leading up to top-line Amarin issued these news releases.

August 2017: Amarin announced results from an interim efficacy analysis after 80% of the 1612 target events were adjudicated.

January 2018: Amarin announced that it had reached the 90% mark for reported and documented primary events.  

April 2018: Amarin announced that REDUCE-IT is estimated to have reached the onset of the targeted 1,612 MACE events, anticipates that MACE from the study will be adjudicated through Q2 2018, and on track for reporting top-line results before the end of Q3 2018.

June 2018: Amarin announced  that the last patient study visit had occurred and reiterated that it anticipates having top-line results before the end of Q3 2018.

So from reaching ~1612 events and completing last patient visit took close to 3 months. Top-line came out after another 3 months. The statement below (my bolding added) from Amarin's June 2018 news release is very important to keep in mind about the potential time between last study visit and reporting top-line results.

"The time between commencing last patient study visits and reporting top-line results in other large outcomes studies reviewed by the company has been approximately five to seven months. There is no reliable correlation between the length of time needed to wind down a study (i.e., the time interval between commencement of patient last site visits and reporting top-line results) and the outcome of reported results of a study.  Amarin’s anticipation of reporting top-line results before the end of Q3 2018 is consistent with the wind-down timing of these other outcomes studies, each of which were conducted by companies much larger than Amarin.......As previously described, other important steps needed to complete the study include finalizing adjudication of reported events, including major adverse cardiovascular events (MACE) within the primary endpoint, securing final vital status data from inactive patients, and completing the review of data for consistency and completeness across more than 35,000 patient years in the trial."

BearDownAZ