CAMBRIDGE, Mass. (TheStreet) -- The thrashing of Aveo Oncology's (AVEO) kidney cancer drug by an FDA advisory panel earlier this month will lead to "very significant consequences" at the struggling company, said Chairman Henri Termeer, in an interview following Aveo's annual shareholder meeting.
Termeer wouldn't elaborate on what "significant consequences" means for the continued employment of Aveo's management team, including CEO Tuan Ha-Ngoc. If a management shakeup is being considered, Termeer wasn't letting on. Aveo executives have the support of the board of directors, he said.
"We are working together," said Termeer, referring to Aveo's board and current management. "As Tuan says, we are very disappointed by this outcome. There will be very significant consequences from this obviously, but for that we need to wait for the company to make its announcement."The value of Aveo's stock has fallen more than 60% since a panel of outside experts convened by the FDA said tivozanib should not be approved for the treatment of advanced kidney cancer. Some panel members and FDA officials used the meeting to sharply criticize the conduct of Aveo's pivotal clinical trial, which showed tivozanib-treated patients were outlived by patients in the control arm treated with Onyx Pharmaceuticals' (ONXX) Nexavar. Since the negative panel vote on May 2, Aveo's corporate partner Astellas has informed the company that it will not pursue tivozanib's approval in Europe for kidney cancer, nor will Astellas fund any new kidney cancer clinical trials. Wednesday's Aveo annual shareholder meeting, held in the aerie offices of a downtown Boston law firm, was the first time company executives spoke in public about the tivozanib debacle. In prepared remarks, Aveo CEO Ha-Ngoc said the company was "extremely disappointed" by the negative FDA panel vote and "dismayed" by the criticisms of the company's actions leveled by panel members. Given the negative panel vote, Ha-Ngoc said the FDA will "more likely reach an adverse decision on tivozanib." The FDA is expected to announce its approval decision on tivozanib by July 26. Ha-Ngoc also used the ongoing FDA review as an excuse to refrain from making any substantive comments about the future plans for tivozanib or the company. The results of an ongoing strategic review of the company's future plans will be announced publicly in the next several weeks, he said.
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