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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

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Comment by longterm56on Feb 09, 2020 12:52pm
72 Views
Post# 30664248

RE:RE:Back to the MGH/DrG announcement

RE:RE:Back to the MGH/DrG announcementThat's not a sufficient explanation, SPCEO.  If canadapiet was told the meeting occurred and the public stance from TH is "We never announced that the meeting had taken place", then candapiet (and all of us) have inside information and stops us from trading.

Holding that  they told canadpiet one thing and they tell the public another thing is untenable ... try again.

   -LT


SPCEO1 wrote: I imagine TH believes there is some good regulatory reason for not confirming they have already had they meeting but Luc already told Canadapiet they have had it and it also makes sense that they have already had it. 

So, it means Dubuc has to stick with the company line that they will not give any specifics about the meeting other than they will have some feedback for us on it before the end of June. Even though he knows that is a silly stance to be taking at the moment. So, his answer just dances around reality because they think they can't tell us the reality yet. I don't think they have to be CYDY when it comes to sharing info and issuing press releases, but I also doubt they need to be this obtuse.  

qwerty22 wrote: I sent off a question to Theratech about Dr G's role with the regulators and got a reply that was somewhat cryptic. Let me know what you think it means.

Question
Could you help me understand one point in today’s press release?

 

 You wrote
 “ The MGH, through Dr. Steven Grinspoon, who is chief of the hospital’s Metabolism Unit, has agreed to assist Theratechnologies in connection with the Study design, selection of optimal patient population, dosing, Study duration and other safety matters and to participate, if need be, in regulatory meetings with the United States Food and Drug Administration (FDA) or the European Medicines Agency (EMA). ”
 
I had the understanding from previous statements made by the company that the type C meeting should have already happened by now but the last part of this sentence suggests that it is still ahead of you. Can you confirm if you’ve already had the meeting with the FDA wrt the clinical trial for NASH in HIV?


Answer (Dubuc)
The statement is not specifically related to the requested Type C meeting. This is a multi-year agreement, and Dr. Grinspoon will participate in any meeting with the authorities (should we require his help), and will assist us in the design of the study, which will be guided by the outcome of Type C meeting. We never announced that the meeting had taken place or the date of that meeting, the only timeframe we discussed is that we would report on the outcome before the end of the first half of 2020.




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