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This is intended to address all items in the FDA's complete response letter for Lumizyme and the submission included clinical data requested by the FDA from Genzyme's Pompe Registry.
Genzyme also sent the FDA its Risk Evaluation and Mitigation Strategy (REMS) and the final label for the product.
It's expected that the filing will be designated as a class 2 resubmission with a six-month PDUFA goal, but Genzyme believes that the FDA may expedite the review process.
Separately, Genzyme reported that it has completed all of the measures required to respond to the FDA warning letter regarding deficiencies at its Allston manufacturing facility. The FDA has now started its inspection process at the plant.
Genzyme and the FDA are also in talks regarding the submission of an sBLA for the 4,000 L-scale manufacturing process and the company expects to file its submission later in the current quarter.
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