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.

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Theratechnologies Inc

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Comment by bfwon Nov 13, 2017 8:18pm

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Post# 26955800

RE:Transparency

palinc2000 wrote: I am disappointed in today s news but not overly concerned as I dont think this will negatively affect the final outcome ,
BUT I am very very concerned by the lack of transparency subsequent to the Oct 28 Meeting...... everything went great we were told .....why???

I think it is possible that everything did go well.

Taimed submitted the amended materials and the FDA people present were likely happy with the documentation submitted.

Upon further reflection, the FDA has decided that the amount of information they submitted is too much to review in a short time period.

So, we have a delay....possibly just on a technicality.

At least it is not a CRL and they have not asked for more info.

Bfw

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