Throughout the Class Period, the Company reported positive results from its satraplatin Phase 3 trial, and indicated that data from the trial would form the Company's New Drug Application ("NDA") with the FDA. The Company reported a 40 percent reduction in risk of disease progression for study participants who received satraplatin, and reported that the study data showed that the results for PFS were highly statistically significant. The Company's investors were shocked on July 20, 2007, when the FDA released its "Briefing Document" in advance of the FDA's Oncology Drugs Advisory Committee's meeting to consider the satraplatin NDA. Therein, the FDA cited five "issues" that it had with the Company's satraplatin NDA. On this news, the Company's shares declined $7.80 per share, or over 24.5 percent, to close on July 20, 2007 at $24.00 per share, on unusually heavy trading volume. On the following trading day, the Company's shares declined an additional $3.05 per share, to close on July 23, 2007 at $20.95 per share.
Then on July 24, 2007, the FDA's advisory panel voted 12-0 to recommend delaying a decision on satraplatin until the Company gathered additional data to determine whether satraplatin actually helped men with prostate cancer live longer. In response, the Company disclosed that it did not expect to have the necessary survival analysis for another year. On this news, the Company's shares declined an additional $7.19 per share, or 35.36 percent, to close on July 25, 2007 at $13.16 per share, on unusually heavy trading volume.
Plaintiff seeks to recover damages on behalf of class members and is
|SOURCE Schiffrin Barroway Topaz & Kessler, LLP|
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