Dr. Bala:
I suspect that when this long standing trial was commenced, PFS, as a surrogate for OS, was selected as the primary end-point. From rad/chemo trials it was recognised that PFS was a good correlative surrogate for OS which would serve to shorten the trial. However, considering immunological approaches, PFS as a surrogate for OS may not be a good correlative. The gold standard is still OS. Due to the length of the DC VAX trial, it now has enough OS data so that the PFS surrogate has less significance than it originally had. And as I have mentioned, even though PFS eventing may not significantly surpass that of SOC, it is within the realm of possibility that the vaccine dramatically slows progression rate such that patients live longer with a better QOL. Such a result, if part of the SAP protocol, would nullify any shortfall in meeting the original PFS end-point. This would be well understood by the medical and regulatory communities--at least one would suspect. It may be less well understood by the short-attentioned general investment community which would likely focus on a failure to meet a trial primary end-point. Thus, although strong data is important, its mode of presentation is also important especially for the investment community. This is where Innes who has experience as a market pro will earn his keep. I believe that is why he was hired. It is critical that top line presentation has a significant and sustaining effect upon the share price. JMHO.
