XML 30 R15.htm IDEA: XBRL DOCUMENT v3.19.2
Restructuring
6 Months Ended
Jun. 30, 2019
Restructuring And Related Activities [Abstract]  
Restructuring

9.

RESTRUCTURING

On June 24, 2019, the Company received a Complete Response Letter from the FDA regarding its New Drug Application for EDSIVOTM (celiprolol) for the treatment of vEDS. The Complete Response Letter stated that it will be necessary to conduct an adequate and well-controlled trial to determine whether celiprolol reduces the risk of clinical events in patients with vEDS. In order to reduce operating expenses and conserve cash resources, on June 28, 2019, the Company initiated a corporate restructuring, which included a reduction of approximately 60% of its full-time workforce of 48 employees and halted pre-commercial activities of EDSIVOTM. The Company recorded a one-time severance-related charge of approximately $1.5 million associated with the workforce reduction in the quarter ended June 30, 2019, of which approximately $1.0 million was included in general and administrative expenses and approximately $0.5 million was included in research and development expenses. As of June 30, 2019, approximately $1.0 million of the one-time severance related-charge was included in accrued expenses on the Company’s unaudited condensed consolidated balance sheet.