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

About the author

Currently residing in New Zealand, Mr. A.Burden holds a Master of Commerce 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‚ĄĘ by June 2014. And their planned submittion of an EMAA in the third quarter of 2014.

    Thank you,


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