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THTX - The Real Value Of A Breakthrough Therapy Designation
Theratechnologies Inc.
The FDA Breakthrough Therapy Designation (BTD) was an offshoot of the Food and Drug Administration Safety and Innovation Act (FDASIA) that was signed on July 9, 2012, that called for a new designation to be created. Since 2012, only 147 drugs have been approved having this designation, which averages out to 21 approvals a year over the past 7 years. BTD is an elite level of review and the biggest beneficiaries have been big pharma, highlighted in the charts below. The real issue for investors is figuring out the impact in terms of value,