Why Is It So Hard To Start A Phase III Clinical Trial in the US? | INSM Message Board Posts

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Msg  52654 of 53012  at  7/16/2020 9:56:46 AM  by

tocentsworth

The following message was updated on 7/16/2020 3:54:15 PM.

Why Is It So Hard To Start A Phase III Clinical Trial in the US?

It seems like we have been talking about a Phase III clinical trial for Arikayce (along with PRO) in frontline NTM, forever. Also, we are told that a Brensocatib Phase III clinical trial in brochiectasis has been given a fast track designation by the FDA, right?
Is the FDA that hard to deal with, even with COVID-19? Just wondering.
 
 


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