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 Wino115on Dec 10, 2020 11:20am

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Post# 32076710

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

Thanks for the intell. This makes it sound likely we would have FDA first, followed by EMA anywhere from 1-3 months later. I suppose the only thing that does is that the Euro centers where they were going to set up the trial will start later. I believe there were 3 of their advisors from Europe, but they all seemed to be involved in the HIV side of it if I recall correctly. I'd need to dust off that list I put up here. It may be they only use those doctors centers for the HIV NASH cohort and not the general population. I would think KOLs like Grinspoon, Loomba and maybe Harrison (if they've consulted with him) would have a list of likely European partners for clinical tests in NASH.

Spartrap wrote: Sorry, I didn't understand you were considering the full validation process (FDA+EMA). In Europe, things are a bit more involved as there is a general EMA decision, followed by a collegial validation by concerned member states, with lots of back and forth possibilities but with tight deadlines. The process is called a CTA (clinical trial authorization). It goes through a centralized portal but I don't think it is public. The whole process takes 60 days at the earliest when everything goes smoothly, and can extend to 106 days for more complex cases according to a document I have, where there are validation issues and requests for information.

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.