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Genzyme recently received a letter from the requestin more information before anapproval — which wouldc enable it to essentially double its production scale could be processed. The company predicts that the finall approval process will take less thansix Genzyme’s response included clinical data that the FDA said demonstrates the clinical benefit of Lumizyme. Also includer in the submission was a risk evaluation and mitigationstrategy (RIMS) overview as well as a finapl label for the product. Genzyme also said it addressed issueds raised in a warning letter sent in Octobee regarding the production of Lumizyme atits Allston, Mass.-baser manufacturing facility.
At the time, the FDA cited problemzs with equipment maintenance, among other concerns. based in Cambridge, Mass., said the FDA is now re-inspectiny the plant. Genzyme said in March that it would ramp downits earning-per-sharwe projection for 2009 to $4.5 per share, from $4.70 per share, due to the FDA At the time, the company said the setback wouldd delay the additional Lumizyme approval by six months. The companyg reduced its projection for the sale of the Pompd disease drugdown $60 million to somewhere betweenh $370 million and $380 million. Patients with Pompe diseasd sometimes suffer from severemuscle weakness, or myopathy. Genzyme’z (Nasdaq: GENZ) shares were trading at $58.
22 in early afternoonj trading Thursday, down from $59.14 a share at the previous day’s close.
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