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Ovoca Bio PLC - Women's health-focused biopharmaceutical company - Says new marketing authorisation application for BP-101 - a novel synthetic peptide administered through a nasal spray - was resubmitted to the Russian Ministry of Health last week by its subsidiary IVIX LLC. Says it is satisfied the concerns raised by the health ministry have now been fully addressed.
"This is a positive development for Ovoca. We are confident that the questions raised by the Minzdrav, related to the CMC and labeling portions of the previous application rather than drug safety or efficacy, have been addressed in this new submission," says Chief Executive Officer Kirill Golovanov.
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By Arvind Bhunjun; arvindbhunjun@alliancenews.com
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