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news.Biopharmaceutical company NeoPharm has met with US regulators and been instructed that an additional trial of its Cintredekin Besudotox drug, for the treatment of recurrent glioblastoma multiforme, is required before it can be approved.
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NeoPharm said it was disappointed by the decision which, if implemented, would significantly delay the introduction of this therapy to the market.
However, the Office of Oncology has encouraged the company to maintain a dialogue with the FDA regarding the pathway forward. NeoPharm said it will consider its options to determine the best outcome and will communicate its plans when they are completed and approved by its board of directors.