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Re: Pablosrv post# 98802

Saturday, 01/28/2017 3:45:55 PM

Saturday, January 28, 2017 3:45:55 PM

Post# of 725687
Pablosrv, you are correct that NWBO has been clear that the data lock process is expected to be "multiple months". Furthermore, it only will start once NWBO knows they have reached the endpoint.

Once the database has been locked though, the process to unblind and publish top line numbers could be a matter of days.

So 2-3 months from "248 reached" announcement to top line data would be reasonable. This also agrees with the work one poster did a while back in gathering data from a dozen or so trials to answer this question.

As far as "full data", that is an ill defined term. The next two clear milestones would be publication at a conference (which of course has external timing issues), and submission of a BLA if the trial works (which would likely be over 6 months from top line data).

P.S., note that the top line data release is potentially being delayed by NWBO being unable to count the events. If 248(?) was reached in November, they would still have not started the locking process because of NWBO's inability to get the count.

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