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Case study

Multidisciplinary Support for a Successful ODD Application

Post thumbnail Multidisciplinary Support for a Successful ODD Application

A US biopharmaceutical client had to withdraw their ODD application during the COMP’s review procedure, due to the lack of substantial clinical data, as anticipated in VCLS’ feasibility assessment.
Two years on, the client asked VCLS to provide expertise to identify the gaps in the studies and recommend a new approach.

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Our Expertise

With several hundred drugs under development for rare diseases, the orphan drugs market is expected to experience a two-digit annual growth rate in the coming years.

Orphan drugs