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FDA blocks early filing for ADC drug, signalling tougher stance

The Swiss biotech said that enrolling such a study would take up to two years, and its plan to file for approval of the drug next year is on hold while it is in dialogue with the FDA about a path forward for the programme.

Likely baulking at the cost of starting a phase 3 study without the prospect of near-term revenues from cami, ADC is halting all investment in the drug for the time being.

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