Example of a partial clinical hold (like the one L is currently under) and the surrounding events.
October 10, 2015 - "Zafgen recently learned of a patient death which occurred in the Company's ongoing double-blind, randomized, placebo-controlled Phase 3 best PWS study of beloranib in Prader-Willi Syndrome, a rare genetic disorder with a high rate of mortality linked to obesity and its co-morbidities. The cause of death remains unknown at this time. According to normal practice, the event was reported to the U.S. Food and Drug Administration, at which point the Agency initiated a discussion with the Company. The Company is working with the Agency to expedite a review and understanding of this event, and to determine implications of the event on the conduct of the trial, and anticipates providing an update as its discussions with the Agency progress."
October 16, 2015 - "Zafgen a biopharmaceutical company dedicated to significantly improving the health and well-being of patients affected by obesity and complex metabolic disorders, today announced that it received verbal notice late yesterday from the U.S. Food and Drug Administration (FDA) that beloranib has been placed on partial clinical hold. This partial clinical hold impacts ongoing or planned clinical trials, including ZAF-311 and ZAF-312." (notice, they had multiple trials put on hold due to the safety incident in the one trial)
October 22, 2016 - "After review of its ongoing clinical trials, the Company has elected to proceed with efficacy and safety data analysis and close the randomized portion of its Phase 3 ZAF-311 clinical trial of beloranib in patients with Prader-Willi syndrome (PWS) and its ZAF-203 Phase 2b clinical trial of beloranib in patients with severe obesity complicated by type 2 diabetes. Zafgen believes that a sufficient number of patients have completed randomized treatment in both clinical trials to assess the efficacy of beloranib and help inform next steps for the beloranib program. Following the partial clinical hold announced last week, the Company believes it can best preserve the integrity of the data in each clinical trial by closing the randomized portion of the clinical trials early. The Company, based on consultation with the U.S. Food and Drug Administration (FDA), expects ZAF-311 to remain a pivotal clinical trial.
In consultation with the FDA, a full assessment of the safety and efficacy data from ZAF-311 will be performed to inform the design of ZAF-312, the Company's second PWS Phase 3 clinical trial. The FDA has informed the Company that it will review the ZAF-311 clinical trial results on the basis of an abbreviated data package. (hmm..dialogue with a regulatory agency and submitting a "data package", sound familiar?)
Who knows if this is similar to what's going on here. But for everyone who posted that a partial clinical hold meant we could definitely rule out this being a safety issue, well here's an example of a trial placed under a partial clinical hold after a patient death.
Here's a question for the board with regard to the requirements for the release of material information. If a company were placed under a partial clinical hold for a "safety incident", but the company strongly disputed the fact that the incident was a result of their treatment and believed instead that it was due to natural causes, do they have to report the incident as a company material event? Is this a gray enough area that someone could make a case for maintaining silence and that they were unaware of anything untoward? I would probably have to consult with a Harvard lawyer on this, but thought I would throw it out for discussion.
