EMA regulatory approval has the requirements like inspections of Manufacturing and supply logistics as one of the evaluation criteria which EMA looks into prior to the final approval. As a Quality Control measures these requirements needs to be fulfilled and DNDN must come out with the final plan as where Provenge would be manufactured, stored and supplied. If DNDN wants to meet the EMA deadline then time is really running out.
CHMP - ORAL explanation requirement is now removed so manufacturing, storage and supply logistics is the next step for getting through the EMA process.
Mark Frohlich, EVP, R&D, CMO, commented on the regulatory process for Provenge in the EU. He stated, "We also continue to make progress advancing the global market opportunity for Provenge. In Europe,
As we have previously disclosed, we are evaluating partner strategies in Europe and continue to enroll patients in the European open label study."
They don't have to announce this. They have stated using a contract manufacturer in Europe already and have kept the location/name confidential. I'm sure review of manufacturing processes / plans have already been part of the evaluation process. However, they do need final inspection approval of the manufacturing facility before final marketing approval is granted. We expect this marketing approval within 67 days of the 6/27th CHMP letter (end Aug., beginning Sept). If I'm missing something, call it out. Thanks,