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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 Aug 25, 2021 8:45am
144 Views
Post# 33760172

RE:MTD

RE:MTD

It's difficult from the outside to know exactly what triggers an announcement but generally it seems to me companies like to announce a set of data, so MTD, toxicities and efficacy. So I don't think companies are obligated to announce MTD as soon as it's reached. MTD can be thought of as a stand alone thing but it makes more sense when you know the doses an efficacy signal is kicking in at as well. MTD is just based on the DLTs from the first dose each patient receives, the overall toxicity profile is based on all doses, that means technically MTD can be the first thing the emerges, but given how late they have this as a milestone announcement I'd guess they aren't rushing to announce MTD as soon as it's reached. I'd expect it's going to be part of a bigger data set. Also Paul's comment that he didn't want the rush things and make an announcement based on n=1 also suggests they want to have the "right" data set before going public.

So yes can't help with the paranoia, MTD might already have been reached but all this might mean alternatively they are also sitting on some shrinking tumours by now and not announcing those. Does that help?


juniper88 wrote: A couple of question for those who might know more about this.

1) If MTD is reached then is the company obligated to announce it?  What have other companies done?

2) If yes for 1) then is there a time lag between reaching MTD and the announcement.  For example, let's say a patient had toxicity on Aug 1 then by what date would it be confirmed that this is MTD?

It looks like another month (aug) has gone by without MTD being reached.  But my paranoia nags at me wondering if MTD could have been reached but just not announce or confirmed yet.

 

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