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 > What's Next?

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Comment by scarlet1967on Oct 21, 2020 12:38pm

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RE:RE:RE:RE:RE:RE:What's Next?

They did issue PRs when Trogarzo's BLA were submitted to both FDA and EMA so I would expect there will be a PR once Tesamorelin NASH application is submitted.

Wino115 wrote: I don't know about the EMA, but for the FDA those are rough timelines. I'm guessing given this new large wave of Covid in EMA they may also be rough guidelines. I'm not sure you'll hear the actual day it's put in but I would guess in some future CC if someone asks, they'll say roughly when it went in and when they expect a response, with all the caveats of dealing with government entities and a pandemic. I could be wrong, but I"m not expecting them to put out a PR the day they file. It's probably not considered material since nothing substantive is decided upon filing.

SPCEO1 wrote: Since TH is asking the FDA to do something out of the ordinary, I am assuming it will take longer to get it all sorted out. Just being conservative. It is possible they get a response before the end of the year.

mikeq113 wrote: SPCEO, can I ask why you're expecting a January response from FDA/EMA? I was under the impression the IND submission was imminent ("within the next few weeks" was thrown around almost a month ago) meaning we'd be looking at a max of 30-60 days putting us mid to late December at the latest.

I was also hoping that after over a year of conversations with the FDA, EMA and their scientific partners, it wouldn't take the regulatory bodies a full 60 day time period to come back with a response.

Another question for the board - will THTX actually announce when it submits the IND and provide any further information or is that unlikely at this point?