The essens of the analysis is that IL-2 does not help, in spite the dose is 7 times higher than together with Ceplene. And, also, the side effect makes patients leave the trials.
As a trace here it seems to be un ethical. In stead of focusing on the problems concerning IL-2, FDA should pay interest to the efficacy of the combination of Ceplene and IL-2. As I understand Griffins analysis there is a possible way using the data from the post approval trial in the EU as a pattern for a SPA-protocol.
The study shows the good relation that management do have in this matter with the Key Opinion Leaders in the US, having this study published in Blood, the leading hematologist paper not just in the US, but in the world. Ceplene is brought forward in an excellent way to the hematologists of the world by this article.
Whatever path the phase III-studie will take the exit rules in the SPA-protocol is of the most important thing to focus on here.