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Message: Re: Bear
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Jan 13, 2020 08:35AM
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Jan 15, 2020 08:32AM
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Jan 15, 2020 09:23AM
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Jan 15, 2020 09:24AM

I hope you’re right, Bear, but my reading of what the FDA has put out on BT status is that it relates to expedited development, not expedited approval. The FDA has a separate designation of “Accelerated Approval”. 

To quote the FDA (my italics):

”Breakthrough Therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. The criteria for Breakthrough Therapy designation require preliminary clinical evidence that demonstrates the drug may have impact on at least one clinically significant endpoint over available therapy.”

 

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