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Message: "Do we actually have a Breakthrough Therapy Designation?"

golf this is the repose I just received from IR.

"Hi,

 

I believe that Wikipedia page is based on this list of approved breakthrough therapies published by the FDA (which the Wikipedia article cites):

https://www.fda.gov/media/95302/download

 

All of the drugs on that list are ones that have been approved for use by the FDA. Apabetalone has not yet completed clinical trials, nor have we submitted a new drug application (NDA) for apabetalone. It is therefore still considered an Investigational New Drug (IND). I believe that is why apabetalone is not included among those drugs listed on the Wikipedia page that you linked. As for your question, I am not aware of any list published by the FDA of INDs (including apabetalone) that have been granted breakthrough therapy designation.

 

Best regards,

 

Chris"

 

Koo

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