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Theratechnologies Inc T.TH

Alternate Symbol(s):  THTX

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

Comment by SPCEO1on Apr 28, 2023 10:40am
113 Views
Post# 35419095

RE:RE:RE:RE:RE:RE:Nothing like some 'leaks' on the FDA Resubmission

RE:RE:RE:RE:RE:RE:Nothing like some 'leaks' on the FDA ResubmissionIt has  been passed onto tome from another shareholder that THTX does not plan to issue a PR regarding the resubmission of the TH-1902 protocol. So, it may have been filed already or it may not have been but they do still expect to be testing again by the end of June.  Of course, the FDA may have questions or may not live up to their own timelines, so there is always risk the restart could take longer.

The choice to not put out a PR for the resubmission is a curious one. While not required, it is a missed opportunity to communicate to the market the TH-1902 trial is one step closer to being real again. To me, not sharing that info indicates uncertainty from management about it and a need to keep the market off balance until they get certainty of the FDA's position rather than let the market know what they submitted and when they submitted it. Since the FDA might materially change things before they approove of the filing, THTX may not want potential partners and investors to know what those changes might be as it might indicate the challenges ahead for TH-1902 are bigger than we realize.
Mannequin wrote: Even worse, they tell us something, but then don't elaborate on it or tell any details about it so it's meaningful and closes the loop. 


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