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Re: Jimbo50 post# 345910

Friday, 01/21/2022 12:09:26 PM

Friday, January 21, 2022 12:09:26 PM

Post# of 462442
Get ready for the Excellence study timeline to be pushed back. Missling is clearly not giving truthful guidance - and this is not the CRO's fault fault. For some reason, he decided to have only a few sites for a rare disease trial.

According to Facebook posts recently discussed, a site in the UK is just getting ready to start enrollment. The trial is 12 weeks long (giving time for a screen would be 14 weeks). If they are still opening sites up, the enrollment target is not close. If we assume the most optimistic (though unrealistic) timeline of last patient screened March 1, 2022 then the last patient last visit would be First week of June - with database lock a couple weeks later. This leaves one week for analysis in order to hit 1H2022 "guidance"....not going to happen. Missling knows this is not going to happen and knew it back at the Q4 CC when he said it (November 4, 2021).

What's realistic? If they increase the four sites currently listed to 8-12 sites maybe they can complete recruitment by 'year end 2022' and report TLD 8-12 weeks later 1H2023. In order to have TLD by end of 2022, they will need many more sites. For comparison, the Lavender study had 187 patients from 21 US sites
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