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Drug & Device News
'Ecstasy' Slated for Phase 3 Trials
The U.S. Food and Drug Administration (FDA) has given the go-ahead to Phase 3 clinical trials of MDMA, also known as Ecstasy, the drug notorious for causing injury and death to users at music festivals and dance clubs. The approval to conduct the trials came after promising Phase 2 trial results showed patients with post-traumatic stress disorder (PTSD) experienced a marked decrease in symptoms after just three doses of psychiatrist-ordered MDMA. Further, the majority of those taking part in that trial — primarily military veterans, rape victims and police and fire department personnel who suffered PTSD because of their experiences — no longer fit the diagnostic criteria for PTSD once the trial was finished. The Multidisciplinary Association for Psychedelic Studies, which conducted the Phase 2 trials, will also conduct the Phase 3 trials.
The DOJ's New Parameters for Evaluating Corporate Compliance Programs
The parameters set forth in the DOJ's memorandum have implications not only for the government's evaluation of compliance programs in the context of criminal charging decisions, but also for how defense counsel structure their conference-room advocacy seeking declinations or lesser sanctions in both criminal and civil investigations.
The DOJ's Corporate Enforcement Policy: One Year Later
The DOJ's Criminal Division issued three declinations since the issuance of the revised CEP a year ago. Review of these cases gives insight into DOJ's implementation of the new policy in practice.
Use of Deferred Prosecution Agreements In White Collar Investigations
This article discusses the practical and policy reasons for the use of DPAs and NPAs in white-collar criminal investigations, and considers the NDAA's new reporting provision and its relationship with other efforts to enhance transparency in DOJ decision-making.
Bankruptcy Sales: Finding a Diamond In the Rough
There is no efficient market for the sale of bankruptcy assets. Inefficient markets yield a transactional drag, potentially dampening the ability of debtors and trustees to maximize value for creditors. This article identifies ways in which investors may more easily discover bankruptcy asset sales.
Second Circuit Reinforces Bankruptcy Code Settlement Payment Safe Harbor
The Second Circuit affirmed the lower courts' judgment that a "transfer made … in connection with a securities contract … by a qualifying financial institution" was entitled "to the protection of ... §546 (e)'s safe harbor ...."