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Theratechnologies Inc T.TH

Alternate Symbol(s):  THTX

Healthcare Biotechnology
Theratechnologies Inc. is a Canada-based clinical-stage biopharmaceutical company. The Company is focused on the development and commercialization of therapies addressing unmet medical needs. It markets prescription products for people with human immunodeficiency viruses (HIV) in the United States. The Company's research pipeline focuses on specialized therapies addressing unmet medical needs in HIV, nonalcoholic steatohepatitis (NASH) and oncology. Its medicines include Trogarzo and EGRIFTA SV (tesamorelin for injection). Trogarzo (ibalizumab-uiyk) injection is a long-acting monoclonal antibody which binds to domain 2 of the CD4 T cell receptors. EGRIFTA SV (tesamorelin for injection) is approved in the United States for the reduction of excess abdominal fat in people with HIV who have lipodystrophy. Its portfolio includes Phase I clinical trial of sudocetaxel zendusortide (TH1902), a novel peptide-drug conjugate (PDC), in patients with advanced ovarian cancer.


TSX:TH - Post by User

Theratechnologies Inc > Why the CRL?
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Post by palinc2000on Jan 24, 2024 11:15am
219 Views
Post# 35842981

Why the CRL?

Why the CRL?Like others I am very unhappy about the messaging.
However I dont have the necessary background nor any informed opinion as to the root cause of FDA s decision...
Apparently the FDA never raised any concerns with F8 until now...Why the change in heart  ? Was it due to sloppy work by THTX or incompetence or is it a result of new guidellines or something else? I dont have the answers and I dont think anyone on this MB know .
FDA issues CRL s quite frequently and even major biotechs and the biggest of the pharmas are not immune to being slapped with a CRL 
Finally I have 2 words to the 2 posters who came out of hibernation this morning to gloat and celebrate the bad news:f o
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