This is more or less what was said...Dr. John Kellum With regard to confidence in the preliminary data, although we have not and we will not conduct any formal analysis of ... data until we complete the trial, we continue to be very pleased with the results so far. Our confidence in the results of the trial remains high.
In November, we published the simulation of the of the likely Tigris results using Bayesian statistical analysis. The paper was published in Critical Care...and was co-authored by our site investigators. The first author of the paper was George Tomlinson, a highly respected biostatistician and expert in Bayesian statistics in the University of Toronto. The results of these simulations furthers our confidence in the final outcome.
You may have noticed, however, that the language that was used, have used in the past, "exceeding expectations” has been removed from recent press releases.
On advice of consultants and in deference to future FDA deliberations, we are taking a more conservative and less quantitative approach to describing our results. In particular, we're steering clear of any language that might suggest that we're conducting interim analysis which would result in statistical penalties.
What we can say, however, is that we're quite pleased with the results and we're confident in the outcome.