I agree that the delay in the release was annoying, but it seems to me that the posters on this board and the Yahoo board were expecting some earth shattering, game changing results from REFRESH 1. That expectation was not set by Cytosorbents, but instead by the folks that post on these boards. There is no way in the world you can expect those kind of results from a 46 patient trial.
Dr. Chan added some color in terms of the objective of REFRESH 1 in response to a question from an analyst, as far back as last August. See the excerpt from the transcript below. In many of the later presentations they specifically pointed out that the goal was to identify which procedure resulted in the higher hemoglobin levels, which would allow them to design REFRESH 2 to target the proper patient population.
“Now in the area of free hemoglobin reduction. This study was never designed to look at statistically significant reductions in free hemoglobin but the FDA and that was designed for pivotal study potentially the De Novo 510(k) study. But what the FDA is looking at the free hemoglobin levels for we believe and what we discussed with them is that they want to know that in this specific patient population where that we've defined through our inclusion and exclusion criteria that this specific patient population is having a problem with free hemoglobin and that will be evident in the control arm data for free hemoglobin after all the data analyzed.”
“So that will provide a data point for the FDA to say yes, this is the appropriate population this is where we've known for a long time that free hemoglobin is a problem, we’ve never had a technology that could remove free hemoglobin before and -- but that this patient population is now validate it. And so I think that is the -- that is what the FDA is looking for going into REFRESH 2. They’re primarily looking at safety, but they are looking at this free hemoglobin endpoint to make sure that we're not barking up at the wrong tree and we're not doing a futile trial right.”
The comments from Chan before the data release and the actual data release itself did show the product was safe and did identify a target patient population for REFRESH 2. Would releasing this data sooner have had a different impact on SP? I don’t think so.
