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Insert Title Here Sean Johnston One of the Most Significant Legal Questions Now Confronting the Biotechnology Industry is the Sc Form

Insert Title Here Sean Johnston One of the Most Significant Legal Questions Now Confronting the Biotechnology Industry is the Sc Form

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uh so thank you for that introduction Dr Ziggler uh you made me sound uh very special uh which I'm not so certain I am and I know with this particular topic um I'm not sure what I'm walking into uh because I I feel like it's a certainly a loaded statement uh that you guys all have uh some examples that you're going to throw at me uh that I'll have to send with I'm going to try to head some of those off uh with some of the examples on my own uh but first I wanted to lay down a little bit of the foundation as to what is expected and all you know the Assumption with this particular statement is that these are you know with the novelty of the technology these are devices being studied under an IDE um and what really should Physicians be doing sites should be doing uh if they come across something that is is adverse um now you can split these into two different categories obviously like I said adverse but also as this particular statem

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