Totally agree Bear. The limitations and caveats are always a challenge for many to remember and accept. New science and specifically biology in our case is a major challenge because it goes its own way. The scientists do their best to design and implement the trial to get the desired result based on the information they have but in the end the science its self will determine the direction we go.
The two single biggest factors that I had determined threw up the biggest challenges for accumulating patient years were, patient enrolment timing because of funding issues (the Eastern Capital backed loan & Hepalink stepping up in a big way) and patient discontinuation rate which we didn't hear anything about until the last year. In my estimation the funding issue added about 6 months to the projected time to 250 events.
This funding delay may turn out to be extremely beneficial to the trial as it will give us and the world better information on long term use of apabetalone.