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Re: Whitewater55 post# 294067

Wednesday, 07/08/2020 5:29:55 PM

Wednesday, July 08, 2020 5:29:55 PM

Post# of 686771
Also included in that June 2nd PR:

The completion process includes final data collection, identification and resolution of queries, data checking and confirmation, and site sign-offs.
All of these functions are performed by independent service firms (not by the Company), with oversight by the Company.
The service firms have completed the final monitoring visits to the trial sites (including a number of them virtually).
The service firms are in the process of resolving the queries from those final monitoring visits (each monitoring visit can generate new queries), and the firms have completed most of the data confirmations.
After the query resolution and data confirmation are finished for a trial site, the site’s investigator needs to sign off on the data before it can be locked.



To me it sounded optimistic that they would have completed the above within 2 weeks of issuing the PR. I suspect that the above (which is largely/totally out of the company control) is taking a bit longer than expected.
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