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BRIEF-Clinuvel Pharmaceuticals provides update on Scenesse FDA filing
September 18, 2017 / 11:33 PM / 3 months ago

BRIEF-Clinuvel Pharmaceuticals provides update on Scenesse FDA filing

Sept 19 (Reuters) - Clinuvel Pharmaceuticals Ltd

* Clinuvel provides update on Scenesse FDA filing

* Clinuvel pharmaceuticals says ‍European post-marketing safety data to be submitted as part of new drug application, expected in december 2017​

* Seeking approval from FDA to market Scenesse in us

* Has agreed with fda that safety data generated under european pass will form part of nda submission

* Safety profile of Scenesse has been positive to date and no safety concerns have been detected from European distribution thus far

* Obtained a positive FDA answer on acceptance of current safety data, as FDA issued a carcinogenicity waiver in 2017

* First full statistical analyses of european post authorisation data are due to be available in December 2017 Source text for Eikon: Further company coverage:

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