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More FDA headaches for QRxPharma

Updated | Biotech QRxPharma’s share price has tumbled after it outlined plans to resubmit its MoxDuo drug application this quarter following meetings with the US Food and Drug Administration.

Carrie LaFrenz
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Biotech QRxPharma’ s share price has tumbled more than 15 per cent after it outlined plans to resubmit its MoxDuo drug application this quarter after meetings with the US Food and Drug Administration, which knocked back its painkiller drug in July.

The group’s shares fell 19¢ to $1.05 following news the FDA recommended the company provide a more extensive analysis of a specific study on efficacy or safety when the revised MoxDuo NDA is submitted. The re-submitted NDA will also be reviewed by an FDA advisory committee, which concerns some market watchers because it opens the application up to more analysis.

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    Original URL: https://www.afr.com/companies/healthcare-and-fitness/more-fda-headaches-for-qrxpharma-20130117-j18h4