ILLUMINATE-206 TRIAL - The $64,000 Question ... | IDRA Message Board Posts

Idera Pharmaceuticals, Inc

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Msg  1642 of 1653  at  6/2/2020 9:41:02 AM  by

auh2oman


 In response to msg 1640 by  raferjack
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Re: ILLUMINATE-206 TRIAL - The $64,000 Question ...

Does the Company have the clinical data from, the Illuminate 101 and Illuminate 204 trials as well as all the translational info to file for a BreakthroughTherapy Designation:
 
 A breakthrough therapy designation is for a drug that treats a serious or life-threatening condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint(s) over available therapies.
 
 
 
https://www.fda.gov/regulatory-information/food-and-drug-administration-safety-and-innovation-act-fdasia/frequently-asked-questions-breakthrough-therapies
 
 
 A new drug may be designated as a breakthrough therapy by the Food and Drug Administration (FDA) if it is intended to treat a serious or life-threatening disease and preliminary clinical evidence suggests it provides a substantial improvement over existing therapies. Once the breakthrough therapy designation is requested by the drug sponsor, the FDA and sponsor work together to determine the most efficient path forward.
 
 
 
https://www.focr.org/about-breakthrough-therapies
 
 
 
We shall see! 
 
 
 
 


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