There's enough information to let us know that Prana has not yet replied to the FDA with information that may remove the Partial Clinical Hold. Whether reporting that only 27 of the patients remained at the end of the AD phase 2 extension study and reasons for the dropouts, plus consideration of the time gaps in the two-year safety study, will be beneficial in the HD study remains to be seen.
Ann: Safety Outcomes of Alzheimer's IMAGINE Extension Trial, page-11
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