Palatin/Mallinckrodt Leutech
Executive Summary
"Complete review" letter issued by FDA for radiolabeled monoclonal imaging agent, Palatin announces Sept. 28. The letter requests additional manufacturing and process validation data prior to approval. Palatin's contract manufacturer for the biologic is DSM. The BLA for the indication of the diagnosis of equivocal appendicitis was filed Nov. 22, 1999 and recommended by an advisory committee in July (1"The Pink Sheet" July 24, p. 32)
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