Question-and-Answer Session
Operator
Thank you, Dr. Bahcall. (Operator Instructions) Our first question comes from the line of Mike King with Rodman & Renshaw. Please proceed with your question.
Mike King - Rodman & Renshaw
Can you hear me?
Safi Bahcall
Yeah.
Mike King - Rodman & Renshaw
I am sorry. I have this tendency to disconnect myself. You gave me a fright there. Congratulations on your progress throughout the year, apologies for my voice, I am fighting a cold. Just thanks for the color on the execution of the SYMMETRY trial. I was wondering if you guys could perhaps talk about a couple of things: so you need 160 events, and if we just do some rough math depending on how you want to look at the outcomes; if you take an average between the two, whether it’s three to go in the five or 1.8 go in the seven, we are looking at a range of about a four to five month time period before you could get the requisite 160 events after last patient enrolled. Is that an appropriate way to think about it?
Safi Bahcall
Mike, this is Safi: let me just clarify the way this trial is designed, which is that we can unblind the data to the analysis after the last patient is enrolled. So, if the last patient is enrolled on Monday we can do the analysis on Tuesday. The point is that we can begin that analysis before the last patient is enrolled; in other words, do the data cut off and begin all the process before then. So, in fact, we would expect to have data shortly after completing enrollment and we wouldn't need to wait five months after completing enrollment. Is that?
Mike King - Rodman & Renshaw
Well, no. What I am saying is, there is sort of a minimum number enrolled to get 160 events, followed?
Safi Bahcall
Right. So, let me just give you an example. If enrollment is going to finish in month X, and you have 160 events month, X minus three months before them, then you would start your analysis around, and then do your data cut off before then. But, by the time you reach enrollment you are looking at a database which has at least 160 events, and you would have your data shortly after completing enrollment.
Mike King - Rodman & Renshaw
Okay, so you would do the data cut off, but the analysis wouldn't be done till the last, so you don't have to spend alpha constantly looking at the data, is that correct?
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