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Message: Re: Timing of BETonMACE data
3
Jun 10, 2019 12:33PM

"Curious if anyone has a good read on when the company is expected to announce top line results. Is it simply a function of the final LSV + ~ 2weeks or is there more to it?"

They can't lock the database until the final query is resolved. Post investigational product (IP) follow up visit and addressing final queries may still need to occur after the LSV before database is locked. Only once database is locked is the data released for analysis.

BearDownAZ

  • Three to four weeks after the LSV, a post-IP follow-up visit will take place either in-person or via the phone to ensure that any safety issues continue to be monitored.
  • Database Lock (DBL) will occur after the last patient’s final visit and the last query is resolved.
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Jun 10, 2019 02:42PM
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Jun 10, 2019 03:06PM
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