Report Claims Dendreon Facing FDA Panel: BioBuzz
By Adam Feuerstein 03/02/10 - 09:10 AM EST
SEATTLE (TheStreet) -- Dendreon's(DNDN Quote) prostate cancer drug Provenge is likely to be brought in front of a U.S. Food and Drug Administration advisory panel, according to an independent and unconfirmed research report released Tuesday.
"We have been in contact with physicians who have been invited by the FDA to participate in an upcoming FDA Advisory Committee Panel Meeting to discuss Provenge," said Elliot Favus of Favus Institutional Research, in a note sent to institutional investor clients Tuesday morning.
The report sent Dendreon shares falling $2, or 6%, to $30.44 in Tuesday's premarket session, mainly because investors do not expect FDA to hold another advisory panel meeting on Provenge. The FDA is expected to issue an approval decision on Provenge on or before May 1.
The veracity of Favus' report cannot be verified. Neither Dendreon nor FDA has announced plans for a Provenge advisory panel meeting.
"I think he's wrong, but even if he is right the panel voted positively last time. The data are stronger this time so I would expect another positive vote and the FDA to approve the drug so that prostate cancer patients can finally have access to this lifesaving drug," said David Miller of Biotech Stock Research, an independent biotech investment newsletter and a long-time follower of Dendreon.
Miller added that Dendreon's management, only last week, said FDA had not been in contact with the company about scheduling an advisory panel for Provenge.
In his report, Favus writes, "We believe that the Street is not expecting an FDA Panel to discuss Provenge and that the announcement of an FDA Panel to discuss Provenge will put significant downward pressure on DNDN shares."
-- Reported by Adam Feuerstein in Boston.
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