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EMA Opinions, page-11

  1. 2,026 Posts.
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    I think the "Applications withdrawn" row is important. Basically - throughout the EMA process - a company gets a good feel for their chances of success - if you don't believe you can answer adequately what is being put in front of you, or if you see that a negative opinion is bearing down on your product, you walk away. That's why so many approvals are given for those applications that go through the whole process. The further you get into the review process, the more likely approval becomes.

    Add to this, it appears that all negative opinions were appealed (1 more appeal than negative, maybe a carry over from the previous years)

    Add to this, TIS has been asked to answer routine questions that normally are put to an applicant AFTER a favourable opinion has been issued. I don't see why the EMA would do this unless they genuinely believed that they were going to approve Vitrogrow. It's a shame we cannot know how many other companies have been put in the same position as TIS, and what their approval rates were. That would be a sweet piece of information.
 
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