The small biopharma company Trevena (TRVN) suffered a setback Thursday after a panel of outside experts convened by the Food and Drug Administration recommended against the approval of its intravenous painkiller. The 7-8 vote means the FDA is almost guaranteed to reject the painkiller, called oliceridine, at or near its review decision deadline of Nov. 2.
But Trevena may have other equally serious problems to deal with in the near future. Earlier this week, investors were told that Trevena’s management, led by CEO Maxine Gowen, misled them for years about the company’s dealings with the FDA.
I’ve covered the biotech industry for a long time, so I’m pretty jaded when it comes to publicly traded drug makers behaving badly. Still, the way Pennsylvania-based Trevena and its management team covered up its serious FDA issues — while telling investors that all was well — is outrageous. At a minimum, the matter should cost executives at Trevena their jobs. You’d hope the enforcement people at the SEC start asking some tough questions.
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