Why didn't Baxter want to see the data?I just re-listened to the conference call. I wonder if Baxter has plans to help fund Spectral beyond the milestone payments and so did not want access to MNPI.
Question: I think you said that you won't be doing any kind of interim analysis or releasing the data publicly before the trial is finished.
Reply: Yeah, that's confirmed. Baxter did not, frankly, want to see the data. John, do you want to address a little bit more or provide a little more color around?
To have an option to “look at the data”...I think as the milestone approached, it became clear to them that there was some risk in examining the data because that could be interpreted as an analysis and frankly they actually didn't want to do anything, even slightly to risk the outcome of the trial. You know this is a small study and a penalty is something we certainly want to avoid.
And we, in our statistical analysis plan, we've never planned for any sort of formal analysis. The goal with Baxter was to really just sort of give them a look at the crude mortality data, but they even wanted to pass on that because of the optics around it, it looking like it was an interim analysis.
And they just didn't want to risk it.
...just to follow up on the corporate side of things, it does allow Baxter to keep its options open, whether it's the potential to participate in a funding etcetera... So it certainly keeps away any potential conflict of interest or possession of MNPI.