UroCor Shares Drop On PACIS Setback
UroCor shares fell sharply recently on the announcement that it expectsto receive a non-approvable letter from the US Food and Drug Administration regarding an Establishment License Application for PACIS, an immunotherapeutic for certain types of bladder cancer.
The company had originally said that it was hoping to realize revenues from the product this year, but stressed that the delay was not a disaster, as its diagnostics business, which makes up 95% of revenues, is unaffected.
The news follows a site inspection of partner IAF BioVac's manufacturing facilities, but the identity of the problems uncovered by this inspection have not been released. UroCor says that it expects to fulfil FDA requirements and gain marketing clearance for the product in 1998.
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