Dendreon Corp: Will Provenge Get Approved?

Echo To All submits: Dendreon Corporation (DNDN) had been downgraded left and right for the last two years by numerous analysts. Even David Miller and other newsletter folks have expressed caution.

Every time there is some sort of positive development, a reiteration of the downgrade comes out… why? (obviously I have my theories).

I just do not understand why these analysts will put their reputations on the line by stating that Provenge will not get approval and go to market when the decision is so close. Mind you, many of these analysts never thought DNDN would even get as far as submitting a BLA for Provenge.

Conditions for Provenge approval have become favorable, yet the analysts still take a blind eye to them. For instance:

1. Provenge targets a medically underserved segment of prostate cancer patients. The patient options are very limited.

2. Provenge increases survivability.

3. Very limited side effects (chills and fever during the infusions… that is it.)

4. FDA/NCI sponsored events which, IMO, was a confession by the FDA that they need to reevaluate how they review cancer vaccines. Supporting the theory that decision makers will look beyond just the statistics.

So, there is absolutely NO safety risk with a drug that has shown to increase survivability to a population that is medically underserved… and the FDA will ask for MORE data, keeping the treatment from getting to these patients for another 2 yrs or so? WHY?

If I were one of these medically underserved patients, and the FDA prevented me from taking this extremely safe treatment because they were uncomfortable with the statistics of the efficacy aspect of the treatment I would very very angry at the FDA.

If I were the FDA, or the committee making the decision, I would allow the treatment to market while closely monitoring concurrent phase 4 studies in order to get a better statistical view of efficacy. I think this is what I think will happen, but uncertainty is still extremely high.

Disclosure: Author is long DNDN