Scoop: On­copep­tides CEO ‘lean­ing to­ward’ giv­ing in to FDA with­draw­al re­quest amid ‘piss­ing con­test’ with reg­u­la­tors

On­copep­tides CEO Jakob Lind­berg is “lean­ing to­ward” com­ply­ing with the FDA’s re­quest to for­mal­ly and com­plete­ly pull its can­cer drug Pepax­to, he told End­points News on Thurs­day, a day af­ter the biotech an­nounced the agency’s ask. But he al­so ac­cused US reg­u­la­tors of a dou­ble stan­dard and claimed it would be un­eth­i­cal to do so, po­ten­tial­ly leav­ing pa­tients in the wind.

In a phone con­ver­sa­tion with End­points ear­ly Thurs­day af­ter­noon, Lind­berg stressed On­copep­tides hasn’t made any de­ci­sion yet and that one would come with­in the “next few weeks.” Lind­berg and his team are still de­lib­er­at­ing whether con­test­ing the FDA’s de­ci­sion and start­ing a po­ten­tial­ly lengthy le­gal process would be worth it.

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