Dendreon (DNDN) Re-Files For Provenge Approval

DNDN: Shares of Dendreon (DNDN) traded as much as five percent higher on Monday morning after the company announced that it has re-submitted its application for the regulatory approval of Provenge, a therapeutic prostate cancer vaccine that was called 'approvable' by the FDA in 2007. According to the press release, the company expects to hear an answer from the FDA at some point in mid-2010.

In 2007 the FDA - after deciding to wait until the ongoing IMPACT trial was completed before reconsidering the approval decision - indicated that they would approve Provenge if certain survivability points were realized; and those points were met in the Phase III trial, so things look good for the chances of a Provenge approval.

It's also important to note, however, that the FDA is still a federal regulatory agency consisting of a bunch of government employees, so nothing is a sure thing - especially in the world of cancer immunotherapy. That being said, I think that the chances of an ultimate Provenge approval are pretty good, considering recent events and past comments by the FDA.

If Provenge is once again pushed aside by the FDA, then I would expect to see a public outcry larger than the one that was ignited in 2007 that saw patients and investors alike join forces to lobby the agency for answers.

In March of that year and FDA advisory committee voted 13-4 that Provenge was effective and 17-0 that Provenge was safe. It was later discovered that two of the Doctors on the panel that voted against the effectiveness of the treatment - and who also subsequently lobbied heavily for the FDA to deny Provenge approval - were found to have previously undisclosed financial interests in companies in direct competition to Dendreon. If you need evidence of questionable ethics by those in positions of regulatory power, look no further than the Provenge Story.

Broad market conditions will dictate the immediate future of the DNDN stock, in my opinion, but I expect the share price to approach the $35 level leading up to the FDA decision in mid-2010.

Additionally, if Provenge is finally granted approval, then it could lead to a nice rally in the cancer immunotherapy sector as a whole.

I continue to believe that immunotherapy is the 'next big thing' in cancer treatment, and a Provenge approval could be the event that brings the treatment to the mainstream.

As always, it's important to remember that the patients in need of the treatment receive the greatest benefits of these treatments; any financial gains enjoyed by investors is secondary in comparison.

Disclosure: No position.