What is EU HTA and why should statisticians care?
The Effective Statistician - in association with PSI
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What's Going to Happen in EMA?
United's 121 is trying to reassure us that this is not how it will happen. We need to have all that ready for submission no later than 45 days before CHMP opinion. And of course there's a concern that has been discussed quite a lot also in all of this. Will we see 27 different questions that we need to address as technology developers? But I think irrespective of how things will probably get more than just one question and it's then up to us to be able to predict that you can say well in advance because we will not have a lot of time.
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