Bavarian Nordic on FDA special status: A huge validation

On Monday, the FDA awarded Danish biotech firm Bavarian Nordic a special regulatory status, which could cut down case processing of the firm’s RSV vaccine candidate. While a phase III trial is slated to begin soon, Bavarian still lags behind in the race to reach the potential billion-dollar RSV market. Still, there’s enough money to go around, says VP of communications, Rolf Sass Sørensen.

Photo: Bavarian Nordic / PR

It’s a feather in Bavarian Nordic’s cap to have been granted the especially sought-after special regulatory status for the company’s RSV vaccine candidate, dubbed MVA-BN RSV, from the US Food and Drug Administration (FDA) on Monday.

The ”Breakthrough Therapy Designation” is meant to expedite the development and case processing of drugs that treat serious diseases.

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