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Companies Reveal Likely EU Review Outcomes Against EMA Advice

 
• By Maureen Kenny

The European Medicines Agency asks companies to wait until they know for certain whether their marketing authorization applications will be approved or not before making any public announcement. Despite this, some companies go public as soon as they hear an early, but non-binding, verdict. The Pink Sheet looks at the issue of “trend votes” and at the companies who decide not to wait.

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Some companies announce EMA trend votes ahead of a final agency decision • Source: Shutterstock

Some companies appear to be going against the spirit of European Medicines Agency advice by disclosing whether or not potentially important new products that are nearing the end of the regulatory review process are likely to be recommended for approval across the EU before the agency has made a final decision. 

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