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Submitted to the fda came from hundreds of patients. If you had used ten patients, its like studying twins in a way because its all the same disease. So if they had used ten patients and given a kind of conditional approval, then everyone would have gotten the drug a lot faster possibly. So things like that, you know, could be in the are in the works. But its difficult to get them working. Jessica, youve outlined the fda is coming up with a new designation, a breakthrough designation status which really fast tracks drugs perfectly. It puts the companies in contact with the data and helps them shepherd it through very quickly. But these Breakthrough Status are for these targeted drugs meaning with cml the package actually is about a thousand patients. But the response we got in the first hundred was the same we got in the last hundred. And so the reality is if we could have taken that first hundred and had a breakthrough desig ....
Brussels Playbook: Germany in recession — Cancel Hungary's presidency? — EU, NATO support grows – POLITICO politico.eu - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from politico.eu Daily Mail and Mail on Sunday newspapers.
In August, in Prague, the chancellor of Germany, Olaf Scholz, said it bluntly: “The centre of Europe is moving eastward.” Russia’s invasion of Ukraine has been a shock to the complacent European order, both to the European Union and to NATO. And it has underscored and enhanced the influence of the countries of Central and Eastern Europe. ....
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