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GPC Biotech Submits CMC Section Of Satraplatin NDA

By Aaron Lorenzo

Wednesday, December 21, 2005
Satraplatin's regulatory review is rolling right along, literally. GPC Biotech AG began a rolling submission of the chemotherapy's new drug application to the FDA, filing the chemistry, manufacturing and controls section. That procedure allows companies with fast-track status to submit sections of the NDA to the agency as they become available, which "is nice because it allows the review process to begin before the complete dossier has been submitted," explained Laurie Doyle, GPC Biotech's associate director of investor relations and corporate communications. (BioWorld International)

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