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Biofrontera Says US Regulator Completes Mid-Cycle Ameluz Review

26th Jan 2016 10:03

LONDON (Alliance News) - Biopharmaceutical company Biofrontera AG on Tuesday said the US Food & Drug Administration has completed its mid-cycle review of its new drug application for skin cancer treatment Ameluz, ahead of its de-listing from AIM.

The mid-cycle review did not result in any additional requests for information nor were any additional review issues noted, Biofrontera said.

"The results of the mid-cycle review support our expectations. With this potential hurdle behind us, we do not anticipate any major delays and we look forward to FDA completing its review in the spring," said Hermann Luebbert, Biofrontera's chief executive.

Biofrontera shares were untraded on Tuesday, having last traded at 2.18 pence.

The company announced last week it will abandon its listing on AIM on February 18 to instead focus on its listing on the Frankfurt Stock Exchange in Germany. Following a review, it said it has concluded the costs involved in keeping its listing in London outweigh the benefits.

By Sam Unsted; [email protected]; @SamUAtAlliance

Copyright 2016 Alliance News Limited. All Rights Reserved.


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