Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : GENZYME - THE KING OF THE BIOTECHS -- Ignore unavailable to you. Want to Upgrade?

To: aliveinsf who wrote (329)	8/12/1998 6:15:00 PM
From: Caveat Emptor	Read Replies (2) \| Respond to of 410

"FDA Piqued by Genzyme Foul-Up...... Boston Herald - 8/12/98 Pg 13 Genzyme Corp is tightening internal controls after having its wrists slapped by the FDA.... The Cambridge Company got a warning letter from the agency last months, the first such reprimand in its 17 year history.... Investigators complained about errors in data accompanying the Genzyme Application to sell a diagnostic test kit.... Neither Genzyme, which makes test kits for hundreds of diseases, nor the FDA would say what the kit in question is intended to detect. But FDA approval is on hold, and the company said it may withdraw the application and refile it later....." The data in question - Patient information - was supplied by an outside vendor.... Genzyme spokesman said "Unfortunately we didn't follow protocol, which is what lead us to receiving this warning letter, but there is certainly no financial impact for the company" Does anyone know what happened here? What drug is involved? How could this effect the short/long term earnings, if the drug is a major player? CAVEAT EMPTOR