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Re: None

Friday, 04/21/2017 6:58:01 PM

Friday, April 21, 2017 6:58:01 PM

Post# of 2099
Remember, the interim is triggered when 105 events have occurred or 50% of the patients have had 12-month follow-up, whichever comes later. The key is to know when 50% of the patients have been enrolled so we can estimate the 12-month follow-up timeframe. As far as I know, that information is not available.

What we know is:

August 2015: first patient dosed
December 2016: enrollment completed

Somewhere in those 16 months, 50% of the patients were enrolled ... but we have to account for the dropouts to obtain the 12-month follow-up. Let's assume 50% were enrolled after 10 months (keep in mind there were only a few locations at first). Add 1 month for the dropouts.

So that brings us to July 2016. 12-month follow-up would hit exactly in June/July in this case.

If the interim is triggered by the 12-month follow-up then that mean the 105 events have occurred. This also makes sense since they seem to be confident on the timing of the interim.
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