Re: Breakthrough Therapy Question
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Message: Re: Breakthrough Therapy Question
I've emailed IR the following:
I'm looking for a bit of clarification regarding the timeline for breakthrough status filing with the FDA that Don mentioned in the December 6th conference call.
When he stated "As we’ve mentioned before, we’re applying for breakthrough therapy status with both the FDA and the EMA. The process will take 90 to 120 days", did the 90 to 120 days include the expected response time from the FDA, or is the FDA's expected response in addition to those 90 - 120 days?
I'll update when I receive a response.
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