Pink Sheet reporter and editors discuss the FTC’s challenges of Orange Book patents, DTC promotion practices as part of acquisition due diligence, and how Intarcia’s advisory committee decision appeal could play out.

Company contends US FDA gave the committee ‘materially false and misleading information’ about ITCA 650 exenatide implant and did not focus on GLP-1 comparative claims as it seeks a hearing before the commissioner following the panel’s unanimous vote against the application.

In another case of criticism after an adcomm, three former Intarcia employees, including the key developer of the ITCA 650 device, contend agency made ‘erroneous statements’ about performance and manufacturing to the advisory committee that voted unanimously against the type 2 diabetes treatment.

A US FDA advisory panel feels there could be a place for Intarcia’s exenatide drug-device combo – if the company is willing to put in the work.