While we'd all like much more by year's end, as I see it nothing may happen, or everything we'd like could, it's all dependent on the submission of the SAP to the 4 regulators. If in fact the SAP's been accepted by the regulators, a criteria for judging the trial is established, and the trial can be unblinded. Clearly, if you unblinded before the SAP, it could be written based on what you already know, rather like being able to bet on a horse race after the race has run.
We know the draft SAP is completed, but we don't know that it's accepted, and if not, how much delay could be caused by any changes requested. At this point, I'm hoping they can unblind by year's end, but it wouldn't be the end of the world if we had to wait another month or two. I do hope they will communicate more with us in whatever time it takes.
ASCO has been the place companies and clinicians like to present major trial data. ASCO wants such presentations to have information that hasn't been previously presented. I suspect that while top line data may come much sooner, and perhaps far more information may come out in smaller conferences where Dr. Liau, etc. are presenting. I believe at this point the complete trial data presented for peer review won't be out until ASCO. The Abstract for filing at ASCO is due in February, as I remember it, but even then an Abstract could be provided that indicated the unblinded data would be presented there, even if it hasn't yet been unblinded, so even the February date isn't mandatory for unblinding the trial. I certainly hope it will be, but Abstracts can be updated once submitted, and most importantly, as long as they are accepted for presentation, all the information actually presented at ASCO can be up to the minute and have a great deal more information than what's shown in the Abstract.
Gary
