Just about every biotech analyst on the planet knows that the FDA is facing a May 1 deadline for a decision on Dendreon's Provenge. As that's a Saturday, we're likely to hear about a final decision on one of this year's biggest new therapies by Friday--and the biotech world is on high alert.
Over at TheStreet, Adam Feuerstein ran an informal poll of those in-the-know and came up with an odds-on favorite of full approval. Waiting for word this week, he writes, "will be like watching for white smoke to emerge from the Sistine Chapel." Over at the home town pub, the Seattle Times concludes that an approval would mark the city's "biggest biotech breakthrough in nearly a decade."
Anything less than a full approval, though, is likely to leave the true believers out there anxiously scouring for every hint available on the FDA's intentions. Dendreon (NASDAQ: DNDN), of course, was famously put off by the FDA after an advisory panel voted to recommend the prostate cancer vaccine--a radical new concept for treating cancer. Forced to return to the clinic, Dendreon mounted a successful confirmatory Phase III at an enormous cost, and proceeded to start assembling its production facilities at three strategic locations in the U.S.
The reason for all the anticipation is the stock price. Dendreon shares closed Friday just above $40 and a consensus of Feuerstein's group saw that rising above $50 on a clear approval. Anything less than that, even a small delay, could cause a rout.