Question-and-Answer Session
Operator
(Operator instructions) our first question comes from the line of Mike King with Rodman & Renshaw
Mike King - Rodman & Renshaw
Hey, good morning. Can you hear me okay?
Safi Bahcall
Yes we can hear you, Mike.
Mike King - Rodman & Renshaw
Okay, quick question. Safi. Let's assume that the trial runs to a successful conclusion in early 2009 with the PSF endpoints, tell us then what happens, I assume all patients on the (inaudible) will then be offered to be crossed over to Elesclomol and what kind of statistical problems will that create, in terms of ultimately seeing a survival benefit?
Safi Bahcall
Hey, Mike. I'm going to turn this over to Eric in a second. But just to clarify, the decision or recommendation to cross over would be up to Data Monitoring Committee, which would certainly be reviewing the results at that point. Just as a reminder, the analysis that we would do for PFS in the first quarter or an early part of '09 is a final analysis for PFS, but it is not the final analysis for OS. So, in that sense, it is interim for OS and we would be talking to the DMC about --
Mike King - Rodman & Renshaw
Right, understood.
Safi Bahcall
Got anything to add, Eric?
Eric Jacobson
Well, this is Eric Jacobson. Mike, I think that, number one, this data goes to the DMC and we get an independent recommendation. Number two, we would plan, and this is already in our pre-specified charter, to discuss the results with the FDA before making any change to the conduct of the trial. So we would have not only the recommendation of the DMC, but discussion with the FDA before any change.
Mike King - Rodman & Renshaw
Right, but that's going to take time and I would imagine that people would want to, if the trial is successful, they'd want to -- why would you want to remain on placebo?
Eric Jacobson
Well I can understand that point. However, I want to remind you that at the time when the analysis is made the trial will be fully enrolled and there will be some time between the data analysis and discussions. So, at that point, it's unclear whether there would be any need to cross over patients.
Mike King - Rodman & Renshaw
Okay and then just a quick question about scanning, can you remind us of the frequency of the scans and how they may be similar or different than the frequency of scanning in Phase 2?
- To read the full transcript on Seeking Alpha, click here »
