On April 30, 2013, the FDA released its Oncologic Drugs Advisory Committee ("ODAC") briefing document (the "Briefing Document") that, among other matters, took particular issue with the rigor of the tivozanib trial.
The Briefing Document also highlighted the regulatory history of Tivopath, and the fact that the Company disregarded explicit FDA recommendations for the Company to conduct an additional Phase III trial, "[a] pre-NDA meeting was held in May 2012. Here, the FDA expressed concern about the adverse trend in overall survival in the single Phase 3 trial ('TIVO-1') and recommended that the sponsor [Aveo] conduct a second adequately powered randomized trial in a population comparable to that in the US." On this news the Company's shares fell $2.33 or 31.31% per share to close at $5.11 on April 30, 2013, on volume of over 15 million shares.
On May 2, 2013, the ODAC voted by an overwhelming majority (13 to 1) to not recommend approval of the tivozanib, because, "the application for investigational agent tivozanib did not demonstrate a favorable benefit-to-risk evaluation for the treatment of advanced renal cell carcinoma (RCC) in an adequate and well-controlled trial." On this news, Aveo shares declined $2.61 per share or nearly 50%, to close at $2.65 per share on May 2, 2013, on volume of over 15 million shares.
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