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Monday, January 18, 2021 12:46:28 PM
The part of interest might be that database lock was achieved as of April 2020 and the publication of the "victorious" interim analysis seems to have been only done by August 2020, so 4 full months after.
Eg it took them 4 months from Datalock to publish the final Analysis summary. It seems a lot but then the FDA approved it in October 2020 ! (not in the document but in this link)
So in summary : Analysis took long, (4 months) after data lock but then the FDA approved right away. Worth noting that the sponsor wanted it to be approved as of Standard of Care, hence they seem to have particularly allowed themselves enough time and no shortcuts to produce a perfect analysis.
Geert told that he wanted a complete analysis because he wants to prove that MK is suitable for Standard of Care. So , although, as someone who is used to people working on data (not on the medical field though), I would tend to think Analysis Time, or at least an undeniable proof of success, should be fast, the shown example study is consistent with what CVM is saying. What I can tell
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