Dendreon Corp fka DNDNQ

[nmstav]

PGS, you say:
"In reading the transcript, I'm also noticing that management is specific that the CMC section will be complete by the end of this year. Are they purposefully refraining from saying "BLA" will be complete? Or is the CMC completion considered synonymous with BLA completion at this stage?"

PGS, don't you think you're being more than disingenuous? Urdal clearly refers to BLA submission, with Clinical section being filed by August, and CMC section by yearend.
Are “purposefully” refraining from seeing the truth....


<<Dr. David Urdal - Dendreon Corp. - SVP, CSO

I am pleased to report that our BLA submission for PROVENGE remains on track. We continue to have a very collaborative and productive dialogue with the FDA. We plan to submit the clinical section of the BLA later this month as part of our rolling submission followed by the chemistry manufacturing and controls or CMC section by year-end. As most of you are aware, there are two key components to the CMC section. The first is the build-out of our commercial manufacturing facility in New Jersey and the second is the scale up of the recombinant protein antigen at Diosynth Biotechnology in North Carolina. We completed the build-out of our New Jersey facility last month and we are now in the process of validating and qualifying the facility to support the required pre-approval inspections by the FDA.

Likewise, we have made significant progress with activities to produce at commercial scale the recombinant protein antigen, one of the key raw materials used in the production of PROVENGE. Dendreon employees together with the team at Diosynth successfully manufactured a series of consecutive conformance lots of antigen, which is a required part of the CMC portion of the BLA submission. We feel very good about our progress, particularly with respect to manufacturing, which can be a stumbling block for many companies seeking FDA approval. I look forward to keeping you informed on our ongoing progress with the BLA and I'll now turn the call back over to Mitchell.>>