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Old 09-16-2018, 07:46 PM
Tupelo3 Tupelo3 is offline
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Tupelo3 Tupelo3 is offline
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Join Date: Mar 2013
Location: New Jersey
Posts: 832
10 yr Member
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Quote:
Originally Posted by zanpar321 View Post
If the present trials show continued safety and success will this drug get fast track status as a breakthrough therapy? Indications so far sure suggest that it qualifies!

Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review
Although maybe it’s technically possible it would be highly unlikely for this to happen. Fast track is used for new molecules that are ground breaking and greatly needed for a particular disease. There is no need for that in this case as this is already an approved drug. It’s available for any doctor to legally prescribe, if they believe it would be an effective treatment. If data comes out to compel the fda, which hasn’t happened yet, it would just make it easier for doctors to prescribe. So, I don’t think the fda would feel compelling pressure to fast track.
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"Thanks for this!" says:
anagirl (09-17-2018), Betsy859 (10-18-2018), jeffreyn (09-16-2018), zanpar321 (09-17-2018)