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BTK-Inhibitor Development: A Researcher's Perspective

Healthcare Unfiltered

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Phase Three Trials - What's the Dynamics of Open Trials?

FDA has recently made statements and assertions that if you want a drug to be approved in the United States, you have to have adequate representation of U of S based patients. And we've seen regulatory activity where where studies done entirely overseas were rejected by the FDA. If they're going to increase those numbers, they got to figure out how to work with frankly, community oncology centers to get those patients on on studies.

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