Scancell Holdings PLC. (SCNLF)

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Scancell's SCIB1 vaccine granted FDA orphan drug status

Scancell Holdings, the developer of novel immunotherapies for the treatment of cancer, said the US Food and Drug Administration has granted orphan drug designation to its SCIB1 ImmunoBody for the treatment of metastatic melanoma.

Orphan drug status qualifies the development of SCIB1 for a 50% tax credit for clinical trials, a waiver of the prescription drug user fee for the drug approval procedure and a period of seven years of market exclusivity following drug approval by the FDA.

During the orphan market exclusivity period, the FDA cannot approve a NDA (new drug application) or a generic drug application for the same product including the principal molecular structure features of the drug and for the same rare disease indication.


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