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
NAVB1.26Lymphoseek12/18/2012Estimate 2H 2014. Company expects CHMP will convene the Scientific Advisory Group on Oncology (SAG-O) during 2H 2014
ALXN167.04Asfotase alfaEstimate 2H 2014 or 1H 2015. Accelerated assessment
OMER22.41OMS3029/10/2013Estimate 2H 2014
OREX5.84Contrave3/10/2013Estimate 2H 2014
INSM14.39ARIKAYCEEstimate 2H 2014
DRTX0.00Dalbavancin12/3/2013Estimate 1H 2015
KERX15.89Zerenex3/10/2014Company estimate mid 2015
MDCO26.54FibrocapsAccepted for filing Nov 2013Estimate 1H 2015
ENTA47.99ABT-45005/08/2014Estimate 1H 2015
KYTH38.31ATX-101Expects partner Bayer to file MAA in 2014Expects partner Bayer to file MAA in 2014
IGXT0.54Anti-Migraine VersaFilmMAA filed Oct 2014Estimate late 2014 or 1H 2015
VNDA12.89HETLIOZAccepted for filing June 2014Estimate mid or 2H 2015
HPTX20.50RAVICTIAccepted for filing June 2014Company estimate 3Q 2015
ACRX6.90ZALVISOMAA filed July 2014Estimate 2H 2015
LGND53.70RevoladeMAA filed November 2014Estimate 1H 2016

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.

2 Responses to “EMA Calendar”

  1. G.M. says:

    Hi Admin,
    Here are two catalyst that may be considered would be more appropriate be posted here as well. The two companies working in partnership IntelGenx Corp. (IGXT) and RedHill Biopharma Ltd. (NASDAQ: RDHL) are expected to produce results of a comparative bioavailability study of their anti-migraine VersaFilm™ by June 2014. And their planned submittion of an EMAA in the third quarter of 2014.

    Thank you,


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