treated patients, were reviewed at a pre-PPPC protocol meeting with FDA in April 1993. FDA approved the initiation of the PPPC trial after those discussions.
The attention paid to this patient's death by the investigators and their acute awareness of the peculiar nature of his presentation were no doubt responsible for their increased vigilance throughout the conduct of the ensuing PPPC study and the rapid termination of that trial when a patient presented with a similar syndrome on June 26, 1993.
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Oclassen Clinical Trial R91-001-10 (NIH Protocol 91-DK-AI-213) ."
Review of the Fialuridine (FIAU) Clinical Trials . Washington, DC: The National Academies Press,
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