Beyondspring’s stock price tripled in August after the New York drug maker said its experimental treatment helped patients with advanced lung cancer live longer. But detailed results presented Monday revealed issues with the conduct and analysis of the clinical trial — leaving the company’s claim of a survival benefit open for debate.
Physicians and investors will argue over the merits of Beyondspring’s drug, called plinabulin, but ultimately, the Food and Drug Administration will decide if it should be approved to treat patients with lung cancer. The company has said it intends to file early next year based on the results from its clinical trial.
That FDA review will be closely watched because it will likely grapple with some challenging issues for regulators: Are data derived mostly from China applicable to patients in the U.S.? And how do you judge a clinical trial that doesn’t reflect the current standard of care for lung cancer patients?
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