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Bullboard - Stock Discussion Forum 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... see more

TSX:TH - Post Discussion

Theratechnologies Inc > This comment from LTF ay be of interest re: NGM
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Post by SPCEO1 on May 27, 2021 10:50am

This comment from LTF ay be of interest re: NGM

Good Morning Everyone, I want to chat a little bit about NGM. First, the two histological endpoints for pivotal Phase 3 NASH trials are- histological NASH resolution without worsening of liver fibrosis or histological improvement in liver fibrosis without worsening of NASH. Aldafermin was successful in the former endpoint but not the latter. The incovenient NASH truth is that NGM fell into the greed trap-this term denotes biiotech trying to achieve the more lucrative endpoint irrespective of what their investigative therapy is designed to do. Mechanistically, resmetirom/MDGL and aldafermin are similar in the sense that they are designed to alleviate fat accumulation with subsequent histological NASH resolution and "some" improvement in liver fibrosis. MDGL has consistently maintained histological NASH resolution as its primary endpoint-that remains the case for the pivotal Phase 3 trial in progress. So why did NGM deviate from an endpoint that is more feasible to mechanism of aldafermin to that which is not???? I don't have any specific answer to that question but it sounds like the greed trap. On release of the data, the usual culprits were blamed---the NASH patients. Based on FDA guidelines, this was a succsessful trial. I am left to ponder whether NGM proposed liver fibrosis to the FDA as the primary endpoint during the design of the trial ???--This is a logical conclusion which explains the abrupt discontinuation of aldafermin for NASH F2/F3 fibrosis. Look at column 4 and row 2 in first table denoting histological NASH resolution. Next, table 2-column 4 and row 1 on the robust liver fat reduction by aldafermin. You all know by now that I am not a fan of short treatment duration of 24 weeks ot less. An ideal treatment duration for NASH study should be 36 weeks and up. FYI, AKRO has followed the foodsteps of NGM/aldafermin-we know how that it will end unless revisions are made. In the absence of unforeseen error or safety signal-MDGL has the sizeable lucrative NASH therapeutics market on approval. This is where we are based on current events.
Comment by PWIB123 on May 27, 2021 10:54am
Assuming MDGL is first to market and "has the sizeable lucrative NASH therapeutics market on approval", where does that leave the opportunity for THTX?
Comment by SPCEO1 on May 27, 2021 11:03am
The author of that info, as well as just about everyone else, believes there will be plenty of room for more than a few players in the NASH space and that many of the drugs will be prescribed in combination therapy because of their different MOA's. So, even if TH is a bit late to the NASH party, it should still be in time to get a nice piece of cake. And NGM's failure really helps TH as ...more  
Comment by PWIB123 on May 27, 2021 11:18am
Thank you for the additional clarity there SPCE01.  I remember you or someone else pointing out the potential and even need for combination treatment plans.  I assume in a market this large, there will be plenty of opportunity and even competitive advantages that become evident with time. I hope new readers on this board can see through the necessary conversations about the reality of ...more  
Comment by SPCEO1 on May 27, 2021 11:23am
Those conversations reflect the reality fo the hole the company dug for itself, even while pulling two huge pabbits out of the hat (cancer and general NASH) in a big bull market. It will not take too much, however, to get that rebranding process for the stock going and for the past sins to be forgotten, particularly by newer investors. 
Comment by qwerty22 on May 27, 2021 1:07pm
Do you know what she means by "greed grab", I'm not getting the significance? Is she just talking about them rushing thru a short trial in order to get to the registrational trial backfiring on them? I take her point that some detail of NGM's program might have worked against them. The short time of the trial maybe worked against the fibrosis endpoint. I can imagine a time ...more  
Comment by SPCEO1 on May 27, 2021 1:43pm
I am not sure exactly what she was referring to but perhaps NGM was choosing a shorter time period in order to get results faster and spend less money but this blew up in their face since it likely takes longer for fibrosis to be halted or reversed. Alternatively, perhaps the way they set up the trial was to go for being the best drug in the space if the trial worked and bit off more than they ...more  
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