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It is too early to determine what effect

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meirluc   Thursday, 06/18/20 12:07:43 PM
Re: None
Post # of 299886 
Quote:
It is too early to determine what effect this update of the anticipated timing of data lock may have on the anticipated timing of the public announcement of data. There may be a similar update to the timing of the announcement of the data as to the timing of the data lock.

The steps that will take place after data lock remain the same as were outlined at the Company’s Annual Meeting. Initially following data lock, only the statisticians will be unblinded (i.e., will be given access to the database containing all of the raw data from the trial). The statisticians will need several weeks to carry out all the relevant analyses and calculations. Then the statisticians will deliver the results to the Company, and that is when the Company will become unblinded. The Company will then discuss the data with key advisors, such as its Scientific Advisory Board and the Steering Committee of the trial, and will address any comments or questions from its advisors as part of preparing the data for public announcement.



As I see it, from now on we may only receive a notice of delay affecting the timing of the TLD announcement. While on June 2, NWBO PRd that data lock is projected to be in force by the middle of June or shortly thereafter, they did not commit themselves to make an announcement if there is an additional DL delay. It seems to me that from here on the only update of any delays will refer to the public announcement of TLD and not to data lock.

We may therefore wait forever without getting any notification regarding data lock.

If within the next 4-6 weeks we do not receive a notification that the TLD announcement will be delayed, I will expect to see TLD by the end of July or early August.





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