12:00 AM
May 10, 2004
 |  BioCentury  |  Regulation

Completely confusing

Genasense Lessons

Completely confusing

Investors and analysts who followed Genta Inc.'s development of Genasense oblimersen closely received a surprise when they downloaded FDA's analysis of the company's NDA on April 30. It was the first hint that an independent review conducted for GNTA had failed to confirm any of the five complete responses (CRs) the company had previously announced.

FDA revealed in its briefing documents, and in a presentation to last week's meeting of the Oncologic Drugs Advisory Committee, that GNTA contracted RadPharm (Princeton, N.J.) to conduct a blinded assessment of response.

"RadPharm was able to verify a total of 40 of the sponsor's 71 responders," FDA reported, including 26 responders from the Genasense plus dacarbazine (DTIC) group and 14 responders from the DTIC group.

RadPharm was unable to verify any of the CRs. The verified responders were defined as partial responses.

There was 49% full concordance for response category between GNTA (Berkeley Heights, N.J.) and RadPharm, FDA reported at the ODAC meeting.

JMP Securities analyst...

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