| Document Date: 2013-11-11 18:52:45
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City Katy Freeway Houston / Philadelphia / Houston / New York / / Company AEs / Neuro-Oncology Working Group / Completed Review / Rosenberg SA / Burzynski Clinic Laboratory / / Event Person Communication and Meetings / FDA Phase / / Facility Katy Freeway / Texas Children’s Hospital / Freeway Houston / Stable Disease / / IndustryTerm study protocol / / MedicalCondition tumor / glioma tumor / High Grade Gliomas / recurrent glioblastoma / Cancer / tumors / headache / glioblastoma multiforme / Progressive disease / nausea / patient’s enhanced tumor / contrast enhancing tumors / hyponatremia / Hypernatremia / atypical myxopapillary ependymoma / contrast-enhancing tumor / neoplastic disease / Stable Disease / malignant brain tumors / contrast enhancing tumor / amended tumor / brain tumor / / MedicalTreatment chemo / radiation therapy / investigational therapy / surgery / / Organization Texas Children’s Hospital in Houston / FDA / / Person Patricia Keegan / Stanislaw R. Burzynski / Perry JR / / Position investigator / private physician / local physician / neurosurgeon / Director / physician / / Product BT-22 / receiving drug / BT-09 / / ProvinceOrState South Dakota / Texas / Prince Edward Island / / PublishedMedium The FDA Safety review / British Journal of Cancer / / Technology study protocol / radiation / MRI / /
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Page |1 Responses to January 7th to March 15th, 2013 (FDA-483) Inspectional Observations Observation 1 An investigation was not conducted in accordance with the signed statement of investigator and investigation plan. Sp