The strength of DNDN's position in any partnership negotiation is derived from the strength of the IMPACT and D9901 data. That data strength is independent from FDA approval which also depends on non-data issues, eg, manufacturing inspection. Having the FDA stamp of approval is great but the EMEA in Europe and other FDA counterparts around the world are perfectly capable of rendering their independent opinions. In fact, many drugs were approved in Europe and other countries long before getting FDA approval.

 

Any pharma big enough to consider a partnership with Dendreon will have the ability to assess the existing data to see (1) if Provenge truly works and (2) if the data is adequate for attempting an application elsewhere around the world. The biggest issue in the current data is perhaps that it was entirely US-based without any enrollment from Europe and/or Asia. That might or might not mean that another ex-US trial will be needed. An experienced partner would be able to assess that possibility. And, if that is to be the case, we circle back to point (1). That is, the partner must have a good sense from the existing data that such a trial will succeed before they ink any deal, regardless of whether or not the FDA gives their stamp of approval.

 

Another potential  roadblock in the partnering process is that some potential partners might also need to evaluate potential competitors to Provenge, e.g., AstraZeneca's Zibotentan whose phase-3 trials on PC will yield data next year. In that way, they can get a sense of how large the potential market share for Provenge will be a few years down the line.

 

IMO, the above issues are large enough to overshadow the use of an FDA approval as a proof that Provenge works. Will FDA approval help with Provenge approval elsewhere? Sure. But, that might turn out to be a more minor consideration among other important factors to be considered by any potential partner. For this reason, I don't see a tight coupling between the partnership timing and the FDA approval. A partnership will happen but it could come any time before or after approval depending on who the partner will be and what they need to consider. As a very long term investor, I could care less when.