Dendreon Will Run on Provenge OK: Poll

SEATTLE (TheStreet) -- Waiting for U.S. drug regulators to make their approval decision on Dendreon's(DNDN) prostate cancer "vaccine" Provenge this week will be like watching for white smoke to emerge from the Sistine Chapel.

The FDA isn't in conclave choosing the next pope. To biotech investors, the FDA is doing something even more important -- deciding the fate of the first drug that harnesses a patient's own immune system to fight cancer. If approved, Provenge will be the first-ever cancer immunotherapy to reach the market, succeeding where many other similar drugs have failed.

FDA is expected to announce its Provenge approval decision on May 1. Since that's a Saturday, Dendreon might get the news Friday. [The speculation that FDA would convene an advisory panel to review Provenge has faded away.]

Dendreon's stock price is up more than 50% since January, but still has room to run higher if FDA grants full approval to Provenge, according to an informal and non-scientific poll of biotech buyside investors and various other biotech sector followers conducted Friday.

Of the 30 respondents to my quick poll, 57% forecast a full and final approval for Provenge.

Sixty-five percent of these "full approvers" said Dendreon's stock price would move higher on the news, with the average price around $51, representing a 27% increase from Dendreon's closing price of $40.10 on Friday.

Three responders to my poll said Dendreon would sell off on news of a Provenge approval; another three people felt the stock price wouldn't change appreciably.

On the other side of the poll, 43% believe FDA will not grant full approval to Provenge this week. All but two of these skeptical responders said unresolved (but fixable) Provenge manufacturing and labeling issues would be the reason for an FDA approval delay.

I only heard from two dead-enders who believe FDA will reject Provenge outright, meaning no approval without new clinical data.

If Provenge's approval is delayed past Friday or Monday, expect Dendreon shares to fall to around $32, according to the poll.

If FDA approves Provenge, Dendreon has said previously that the company is ready to launch the drug within 24 hours. If Dendreon follows through on this plan, Dendreon CEO Mitch Gold gets about three hours to enjoy the good news from FDA before investors start worrying about the Provenge launch.

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