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 > From unjustified optimism to unjustified pessimism

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Comment by SABBOBCATon Jan 10, 2023 9:18pm

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Post# 35214811

RE:From unjustified optimism to unjustified pessimism

This!

scarlet1967 wrote:
“The mandate of this Scientific Advisory Committee is to optimize the protocol amendment for the development of TH1902.”

He said optimize not validate!

“Questions raised by the FDA were already being addressed by our team as part of our sub-analysis of the data accumulated so far, and we are confident that we will be able to address all of their questions. Finally, the FDA indicated that their review of the protocol amendment would be completed within thirty days of submission.”

To me it surely sound like they will go ahead with it.

So for those who are speculating about the validity of their approach and alternatives as a reminder not only experts have to design it but FDA has to approve it as it has to be convincing arguments that restarting the trial doesn’t harm the patients and has a logical reason why it can benefit patients.

We don’t have access to data in order to even hypothetically predict what is the rationale, the scientists performing sub analyses have.The company’s job is that the restarting of the trial is safe and worth the risk of allocating resources. If they say they have already address the questions asked by FDA and/or are confident they can address them and FDA already have said the amendment will be assessed within 30 days to me it means the decision to pursue with it has already been taken. At times the board has been over optimistic about this project and now in my opinion too pessimistic most likely because of skepticism. I believe they need to explain much more in detail about the protocol so investors can build an educated thesis. If the company is convinced about their approach convince the market to the best of your ability, this time the decision is based on data from humans so the presentation has to have the details from new findings. If they want to deal with skepticism about the future of the trial and the sort1 platform they need to share as much as possible details before the restart, they used/shared the preclinical data to validate the decision to start the trial now they are using human data, so they have to share the details with their investors so the market understands restating of the trial is a legitimate decision both scientifically and financially. I can’t emphasize enough how important a much improved communication about their operations is.