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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 Wino115on Jan 22, 2021 3:51pm
187 Views
Post# 32361841

RE:RE:RE:RE:Getting a Green Light rather than a Yellow Light from FDA

RE:RE:RE:RE:Getting a Green Light rather than a Yellow Light from FDA It would not surprise me that the 3 large anchor investors know a bit more because they would have been able to get all the top guys on one call and dig much more than we can. I can tell you that I never would become an anchor, stuck in a microcap, without having all my questions answered by management. Obviously with the regulations around news, it couldn't be something "material", but there's a lot of ways to ask questions to sus out more details around something already announced publicly.  So publicly they've stated there's a few points they need to clarify on the trial -- they can discuss with some the general "topics" involved and not worry about the regs. I would almost guarantee those guys know more than we do on some specifics. If they don't know more, they shouldn't have invested. Wouldn't surprise me if they know a bit more on EMA either. It's all about asking the right type of question.


On the vaccine down here, just a quick thought. I'm not exactly sure where the numbers are, but they change a lot.  One common thread is there's a bizarre belief (I heard it from a 80+ year old aunt) that the two mRNA vaccines "impact" your own DNA. It's those kind of scare stories and a few on the severity of the second dose that has kept the survey's low. I think that will change once you get the AstraZeneca/Oxford (which is vector I think) and the JnJ one.  The JnJ is an adenovirus version I think. If it isn't, there is an adenovirus one about to go for final approval (maybe the other German one CurNVac).  Given those are more like traditional vaccines and from a "brand name" US company I think you'll find the survey numbers go up in time. At some point between those with antigens and vaccinated, you should get a pretty high number that stops the spread.  It wouldn't surprise me that as we see lots of business and countries demand a proof of vaccine and millions more not growing a third eyeball that you'll see all the holdouts line up and get it done. 

palinc2000 wrote: Fda requesting a Meeting to discuss questions and commentson certain aspects of the proposed trial design  is not a Green Light ,,,,,at most it would be a Flashing Yellow Light
qwerty22 wrote:

The fact there is room to argue the colour of the light is the issue. 

 

SPCEO1 wrote: I think it would be closer to the truth to say the light is just a lighter green, not yellow. The FDA has approved a phase III NASH trial and just has some additional guidnace they want to give. At least that is the impression management has left with the way they have described it.
 

 

palinc2000 wrote: is a pre requisite IMO before management can go all out on attracting Institutions and major players

 

 




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