Question-and-Answer Session
Operator
The question-and-answer session will be conducted electronically. (Operator Instructions). Let's hear from Thomas Wei with Piper Jaffray.
Thomas Wei - Piper Jaffray
Hi. Thanks. I had a question on your comments about the look at the blinded data here on both efficacy and safety. So should we interpret that you mean that on a blinded basis the overall valvulopathy have engraved in the trial looks very linear?
Jack Lief
So as far as valvulopathy is concerned, of course we have the benefit of the Echo Safety Monitoring Board which gives us significant amount of confidence, that our assumptions when we started the studies were pretty much right on. So Bill do you have anything to add on it?
Bill Shanahan
I do not think really, you have added much more to that. That we did not meet stopping criteria and certainly our blinded review of the data is very encouraging, all of the safety data is within what we would expect for the population. We obviously are not unblinded, but the blended event rates for things could be a concern within what we would expect. So, we are not seeing any patterns that are concerning to us.
Thomas Wei - Piper Jaffray
So you are able to look at the shape of that curve over time on a blinded basis. Do you know if you have access to the data on valvulopathy event rate for drug like fenfluramine overtime? Can you actually plot that out and see what happened before?
Bill Shanahan
Unfortunately we can not because none of those studies were done prospectively. So as we mentioned on numerous other phone calls that the database just does not lend itself to that kind of analysis. It is all prevalence rate, so people were just pulled in after they had been on Fen-Phen for varying amounts of time, days, weeks, months and then took a snap shot and compared to placebo groups that may have been included or may have been included together from case controls or whatever.
I think the best summary of that was that, it is a meta analysis by which he looked at. Basically he broke it into trials that have three months or less of lean exposure and those that had three months or have greater than three months, and found with the FDA valvulopathy definition roughly of 12% versus 6% rate, so about twice the rate in trials that had a mean exposure of over three months.
- To read the full transcript on Seeking Alpha, click here »
