Biotech Values

[DewDiligence]

SRPT BoD limits CEO’s participation in FDA meetings:

http://online.wsj.com/articles/sarepta-ceo-gives-up-some-of-his-broad-sway-over-management-1406661188

Sarepta Therapeutics Inc…recently moved to limit Chief Executive Chris Garabedian's broad sway over operations, especially his role in discussions with the Food and Drug Administration. The step was taken in response to the concerns of some company executives who worried Mr. Garabedian's involvement in the regulatory discussions was counterproductive, according to people familiar with the matter.

…Mr. Garabedian's management style has also become a point of contention among some executives and is blamed by some for a spate of employee departures, according to people familiar with the matter.

Sarepta Chairman William Goolsbee said at a July meeting of the company's executive team that Mr. Garabedian would no longer attend the biotechnology company's meetings with the FDA, according to two people familiar with the matter.

…Some employees at the company had become concerned Mr. Garabedian's presence at previous FDA meetings, in which he forcefully defended Sarepta's view that its lead drug eteplirsen should be approved before the completion of a late-stage study, had been counterproductive and alienated regulators…

Mr. Garabedian's role at the FDA meetings was among the concerns Dr. Krieg [the former CSO], who was fired last week after joining the company in January, raised with members of Sarepta's board of directors in recent months… Without providing further detail, Cambridge, Mass.-based Sarepta said in a filing last week that Dr. Krieg had been terminated from his position [#msg-104611440].