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Palatin/Mallinckrodt Neutrospec Clears FDA; Imaging Agent Available In Mid-August

This article was originally published in The Pink Sheet Daily

Executive Summary

The radiolabeled monoclonal antibody is approved for diagnosing equivocal appendicitis. Palatin expects to initiate a Phase III trial for diagnosing osteomyelitis by the first quarter of 2005.

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“Dear Doctor” Letter Cautions About Cardiopulmonary Events With NeutroSpec

Letter from Mallinckrodt and Palatin alerts healthcare providers to serious cardiopulmonary events that may occur within minutes of injection with the imaging agent.

“Dear Doctor” Letter Cautions About Cardiopulmonary Events With NeutroSpec

Letter from Mallinckrodt and Palatin alerts healthcare providers to serious cardiopulmonary events that may occur within minutes of injection with the imaging agent.

Palatin/Mallinckrodt LeuTech Is Now NeutroSpec; Second Quarter Approval Predicted

FDA requested trade name change to avoid confusion with a currently marketed drug, Palatin says. NeutroSpec is pending at FDA for diagnosis of equivocal appendicitis; Palatin completed all BLA amendments in first quarter of 2004.

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