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flipper44

12/05/15 1:38 PM

#46459 RE: Ready4bluesky #46457

This is the way I thought about it.

If the reason for the halt can't be given due to trial integrity and not interfering with the regulatory decision process, then management can't project the reason for the hold. Moreover, they have the 20/20 excuse down the road, that had they not had enough patients to complete enrollment in the pipeline, they would have needed to reopen it. That's how I make sense of it. LP was very careful with her wording, as I posted a while back, at the London conference, not to use the word "lifted" when describing future possibilities regarding the partial hold.

As of October 30, things changed again, with clinical trial.gov stating "active, but not recruiting" meaning, the study is ongoing but potential participants are not currently being recruited or enrolled.

Under a possible scenario, at least to me, that could be when enrollment completed. Previously, I've referred to clinic opening rate and size to support this possible scenario.