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Episode 61

Biotech Hangout

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The Importance of Regulation Flexibility in Europe

Josh: I learned something that I didn't know reading an ISI report from one of Josh's colleagues, which is so the company. So basically they've said that, you know, they expect the CHMP to reject it and they're going to resubmit right away. Chris: For decades, we used to always think of Europe as like the easiest route to market and FDA being a much tougher route. Brad: Is that dynamic flipped? And also, I know that regulators aren't supposed to be thinking about this, but like, is money coming into play here?

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