EMA Calendar

European MAA Calendar. Approval date uses 13 month estimate following filing. Review period is 210 days PLUS additional time for review/consultation. Note there is NO definitive timeframe. Treat dates for CHMP recommendations as ROUGH ESTIMATES ONLY!!!! Readers are advised to pay more attention to the text in the “Link” column with regard to estimated decision dates, rather than the date in the “CHMP recommendation” column.

Company InfoPriceDrugFiling Date (approx)CHMP Recommendation (estimate ONLY)Link
NAVB1.75Lymphoseek12/18/2012Estimate 1H 2014
ALIOF97.55Macitentan (Opsumit)Filed Nov 22 2012Estimate 1H 2014
ACUS0.87ImagifyEstimate 2Q 2014
OMER12.29OMS3029/10/2013Estimate 2H 2014
NKTR12.26Naloxegol08/26/2013Estimate 2H 2014
OREX5.70Contrave3/10/2013Estimate 2H 2014
DRTX13.45Dalbavancin12/3/2013Estimate 1H 2015
KERX14.23Zerenex3/10/2014Estimate 1H 2015
MDCO25.53FibrocapsAccepted for filing Nov 2013Estimate 1H 2015
KYTH38.99Expects partner Bayer to file MAA in 2014Expects partner Bayer to file MAA in 2014

About the author

Currently residing in New Zealand and employed in the education industry, Mr. A. Burden holds a M.Com in International Business from the University of Sydney and used these skills together with his passion for investing to establish BioPharmCatalyst in June 2010 as a tool for investing decisions in the US pharmaceutical market. He spends much of his free time mountain biking, playing squash and hiking.
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