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Features and benefits * Step-by-step appraisal of complete response letter requirements for Qnexa, Lorqess and Contrave * Assessment of planned approaches taken in response to regulatory demands, including evaluation and interpretation of corporate pronouncements * Contextualisation of strategic and tactical approaches against broader regulatory and corporate considerations * In depth assessments of likely outcomes and ramifications for Vivus, Arena and Orexigen Highlights Vivus appears to have contingencies aimed at securing approval for Qnexa prior to regulatory change.
The lease signing marked the culmination of a more than year-long effort that involved research, negotiation and execution of a lease, due to complex work letter requirements, including the need for individual and supplemental HVAC controls, built-in workstations and dozens of 30 private offices," Nuzzolese said.
The doctor's letter requirement "went out the window almost immediately," CIA spokesman Mark Mansfield tells The Washington Post's Vernon Loeb.