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Message: BTD

Much is always made of the BTD that Apabetalone received and its advantages. Below is the FDA's description of a BTD. Notice the phrase, "to expedite the development and review".

"Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s)."

I have no knowledge of the operation of the FDA but often wonder what they think after issuing this designation and two years later, the company itself shows no interest in "expediting" the BoM2 trial. 

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