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. It blocks viral entry into host cells while preserving normal immunologic function. The Company is also investigating an intramuscular method of administration of Trogarzo. 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.

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Theratechnologies Inc > Almost 8 weeks..... since they said, in coming weeks

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Comment by Spartrapon Dec 10, 2020 9:57am

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Post# 32075965

RE:RE:RE:RE:RE:Almost 8 weeks..... since they said, in coming weeks

No, they haven't. It's an IND, it's 30 days top for a negative answer, and a positive answer can come any day before that. Also the title of this thread makes no sense to me. The NASH announcement was on Sept 10th, that is 3 months or 13 weeks ago.

Wino115 wrote:
Knowing the exact day isn't all that helpful given regulators have a wide period to review it and with COVID we know those are somewhat extended beyond the normal. So it may be easier to think that regardless of whether it was filed last week or in 4 weeks, they should pass the regulatory issue towards the Feb, March timeframe and ramp up the study after that.

I know the FDA doesn't list submissions anywhere, but does anyone know if the EMA does? Maybe they're more in to disclosure in official publications.

palinc2000 wrote: I for one was hoping thatt hey would have issued a PR upon submission but I see near zero chance that it has not been filed,The imminent comment by Paul meant just that ,,,,,The clock has been running a couple of weeks and FDA s response should fall within the expected time slot

Bucknelly21 wrote: I'm not sure what you guys are implying, you or I have no idea if it's already been done yet. Most likely it has.