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Re: meirluc post# 296231

Thursday, 07/23/2020 4:26:20 PM

Thursday, July 23, 2020 4:26:20 PM

Post# of 732722
How are you guys finding what sites are complete, I've not seen that sort of information from the company, but you no doubt have sources that I don't.

I suspect that even if one living trial patient couldn't be found to verify they're still alive they'd wait on the lock, but everything else would be collected under soft lock. That's just my view, I'm no expert, but I don't believe in a final report you want even a single LTFU if in time they'll be found, and they're believed to be alive, and hopefully healthy.

If something that minor was what was holding up data lock, I believe the contractor could have well over 99% of their work done, get that one tiny bit of information in and they can finalize their work in minutes. Data lock would be called, the company would get the report, then it's about how long before they issue TLD, could be days, could be weeks, or it could be hours if the contractor was tasked with preparing a recommended TLD statement, and the company agreed to what they said.

Gary
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