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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 qwerty22on Oct 10, 2022 1:00am
114 Views
Post# 35015341

RE:RE:RE:RE:RE:Recent study

RE:RE:RE:RE:RE:Recent study

https://www.biocurate.com/resources/proof-of-concept-industrys-perspective/

Looks like a good description of proof of concept. As this says it can be a moving target and context matters. If you took this 'practical' definition from early in that article rather than some of the scientific driven definitions then my guess is PoC comes when they hit the first go/no-go decision point. 

"For industry, POC almost always applies to clinical trials. POC studies are usually small and designed so as to provide early statistical evidence allowing drug developers to make the decision whether or not to proceed into larger, more expensive Phase 2b or 3 clinical trials."

It does say statistical evidence and at 10 patients the stats will be pretty thin but I think it's plausible. So I've been saying 2 responder from 10, don't take that as gospel, but if that triggers expansion in one particular cancer and is ok'd by the fda then that seems as good a time to call it as any.

As that article points out later you can work based on more scientific PoCs, such as the one Jfm is pointing to now. Seems like a hard ask to me until you have more patients.

To be fair Paul called the 3 patients they highlighted "signs of efficacy". That's a pit stop on the road to PoC for sure.


Bucknelly21 wrote: While i always appreciate jfms posts he also say we basically had proof concept without them actually saying it and bow it seems hes saying we need to have data showing the link between the results and sortilan 

 

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