In his Monday morning trading call, Vector SecuritiesInternational analyst Peter Drake said that Centocor Inc. andthe FDA are close to a decision on proceeding with theapplication for marketing approval of Centoxin.
"We believe that Centocor is likely to imminently announcethat they have reached a mutually beneficial accord with theFDA that will result in Centoxin moving forward towardregulatory approval without the use of a placebo-controlledtrial," Drake told BioWorld.
Centocor shares (NASDAQ:CNTO) rose 75 cents to $14.38. It wasthe most heavily traded biotech stock on Monday, with avolume of 3.2 million shares.
On April 15, Centocor announced that it had been informed bythe FDA that the drug, a monoclonal antibody for gram-negative sepsis, couldn't be approved on the basis of theMalvern, Pa., company's clinical data.
An FDA spokeswoman had no comment on the report. Centocordidn't return phone calls. -- Karen Bernstein
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