Possible FDA Delay Sinks GPC Biotech

GPC Biotech's(GPCB Quote) stock plummeted Wednesday as investors reacted to an advisory panel's unanimous recommendation that the Food and Drug Administration wait for more information before approving prostate cancer drug satraplatin (Orplanta).

Speculation began last week when the Oncology Drugs Advisory Committee released a brief in preparation for this week's meeting that questioned the research's methodology. According to trial data, satraplatin patients lived a median of 11.1 weeks without their disease progressing, vs. 9.7 weeks for placebo patients. But ODAC was concerned with how the disease progression and pain were measured -- and whether this was acceptable for the drug's accelerated approval.

Worries were confirmed when all 12 members of the panel voted in agreement that the agency should wait for the overall survival data.

"We believe the panel didn't have time to study our very strong data that show even in the worst-case scenario, there is a highly positive effect," GPC's CEO, Bernd Seizinger, said in a conference call Wednesday. "As you may have noticed, there were no radiologists on this panel." He remarked that they did have a world-class radiology expert with them but that he didn't have a chance to speak.

The company said that prior to last week it was unaware that the review staff had issues with its implementation of the endpoint in question. "That came to us as it came to you -- in the briefing document," Seizinger said.