There are some dense arguing here. We had this in Europe before the Cro Magnon.
There are some clarification to be done:
The FDA opinion is preliminary, and is not a rejection on the efficacy of the combo Ceplene/IL-2, p-value 0.008. That is important. The thing FDA wants Epicept to show is, when IL-2 already is in the market, if Ceplene is adding or being synergistic to IL-2 or not at all.
May that be possible to show after a conditional approval? Or is the problem, given that there are several dense reports on the non-existing significant (p-value below 0.05) efficacy of IL-2 preventing relaps after chemo theraphy, of another kind?
Is it correct of the EMA in Europe to say that it is an ethical problem to start an arm giving just IL-2, when the latest research (see last ASH) says there is no significant efficacy?
Is it right or wrong that the Ceplene / IL-2 efficacy should be taken inte consideration because there are no alternativ treatment? There is not 3-4 other alternatives here. Patients will acctually die out there.
Is it possible to find an opening in new figures from the trial using biomarkers to find out h o w Ceplene/IL-2 works. Might that trial be compaired to other existing trials where IL-2s values for this biomarkers have been studied?
Epicept have several times this summer said that they will give us new updates on OS. Is those figures an opening?