BDZ,
Those are the rules and you explain them very well and clearly,... But as we see, the FDA is softening a bit.
If you took any ordinary person and showed them the results we had with Stroke where we just failed,... and then you show him the results of CHF where we passed with extreme colors,.. without and other info like Primary or Secondary endpoints etc,...
Each and every person would say: ALLOW the drug to be available to the public.
What us lay peolple don't understand is the rules that have been implimented to NOT allow great results to be made available because of the LABEL,.. SECONDARY ENDPOINT.