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EMA Opinions, page-3

  1. 529 Posts.
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    You are correct Timber in that there are 2 categories - "new medicines" and "extensions of therapeutic indications", however Vitro Gro is considered under "new medicines" even though it has been designated a device, albeit with therapeutic properties.

    After reading your post and having a second look at the key CHMP statistics I noticed that below the figures for February, in very small print, was the notation "total for 2015". Thus total positives for "new medicines" was 10 and for "extensions of therapeutic indications" was 11, giving a grand total of 21 positives and zero negatives to date.

    My apologies for any confusion.
 
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