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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 > 10 questions from RBC January 8
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Post by scarlet1967 on Jan 14, 2021 10:32am

10 questions from RBC January 8

These are the questions the company has to address in convincing manner to gain the confidence of not only institutional investors but also the more atm relevant retail investors. I think the conservative analyst at RBC still questioning the NASH phase is stupid as they clearly stated it will be phase 3 also although the sales are important too many questions are related to legacy drugs rather than R&D programs emphasizing the company’s strategy to shift the focus to more promising R&D programs has not worked so they need to a new strategy imo. As per the last question the answer was giving away a large portion of the company for a dreadful price.
 
 
Theratechnologies Inc. (THTX) – Sector Perform, $2 PT 1) Can you speak to how reimbursement is progressing in the EU, how uptake has been in countries where you have successfully negotiated, and where you are focusing your commercialization efforts next? 
2) Can you comment on the Chief Commercial Officer transition, especially given the timing—in a pandemic, during the SV launch and reinvigoration of Trogarzo efforts—and when can we expect a replacement? What factors do you think contributed to better than expected commercial performance in 4Q?
 3) Can you discuss the commercialization dynamics for Trogarzo, and in particular how the pandemic is impacting the renewed push to doctors and patients? How is access to Trogarzo given the disruptions to hospitals, and are you able to successfully transition patients to receive infusions at home or in the clinic?
 4) What have been the greatest challenges in getting in front of doctors and increasing awareness and use of Trogarzo? What has their feedback been on the drug, and how is the sales team adapting to telemedicine? 
5) How do you see the competitive landscape evolving in HIV, with new agents for treatment-resistant patients and long-acting inhibitors from major players such as GILD, MRK, and GSK on the horizon? What advantages do you see for Trogarzo, and is there room for multiple drugs in the treatment paradigm?
 6) Can you speak to how efforts to commercialize Egrifta are going, and how has the feedback been on the new SV formulation? Has the commercial performance in 4Q been due to sustainable growth across both products, or are there any inventory and stockpiling effects that may have contributed to the recent beat?
 7) Can you provide some additional color on what the feedback from the Agency has been like on the proposed NASH trial, and what has the tone of interactions has been? Have they agreed that you do not need ph.II biopsy results or an adaptive ph.II/III design, and can you speak to what types of remaining questions they have that will be addressed at the future meeting? 
8) Can you speak to what the finalized trial protocol for NASH looks like, what the powering might be in light of the larger trial, and what the expected timeline is for the interim and complete analysis? How have you designed your trial to maximize the PoS given the difficulty that other companies have had in meeting the high bar in NASH?
 9) Can you provide any additional granularity on the sortilin strategy—what is the level of efficacy you are looking for in the 40-patient ph.I trial to make a go/no-go decision, and would you be comparing it to docetaxel? Is there a particular indication among the ones you have chosen that you may be most excited about, such as breast/ovarian? When can we expect data from the ph.I trial, and when can we expect an IND for TH1904? 
10) Can you speak to what sort of capital and strategic options you are considering given the expectation of running a large ph.III NASH trial and also entering the oncology space with the 
Comment by SPCEO1 on Jan 14, 2021 10:40am
In theory, Abrahms has already asked these questions and gotten an answer. Why did he put this list together - is TH participating in a RBC conference call?  On NASH, I asked the company if there is any going back to phase IIb and was told that is not in prospect at this point. So Abrahms likely already knows that too. I guess he just does not believe it.
Comment by Wino115 on Jan 14, 2021 10:43am
thanks for this  all great Q's.  Also shows RBC has no interest in the pipeline value until post data on cancer and some proper interim read on NASH. So definitely the guy who will up their target from $2 to $5 when it's trading at $5.  He will not look at comps and NPVs until the pipeline risks are way lower in his view.  Has no interest in doing it and is more ...more  
Comment by scarlet1967 on Jan 14, 2021 10:55am
Most of questions are relevant but it seems there are so much pending doubts regarding company's ability to execute so even when they produce good results it won't be factored in by the market, I  believe the problem is the failed IR and inability to convince the investors of course the recent deal wasn't helpful at all. But if company can address these questions in a convincing ...more  
Comment by scarlet1967 on Jan 14, 2021 12:32pm
These are two of the analysts covering us, well in both cases it seems tossing a coin has better success rate than following these analysts. Brian Abrahams's Performance Success Rate 48%   168 out of 351 ratings were successful   Edward Nash's Performance Success Rate 43%   75 out of 176 ratings were successful
Comment by qwerty22 on Jan 14, 2021 12:57pm
I see cancer as data driven, it's hard to ignore ORR or DOR, they should speak loadly, I guess you could ignore them if you want to focus on corporate competence. Here's a meta-analysis of mTNBC lots of numbers to pick out of that but my summary of the present tested drugs. https://breast-cancer-research.biomedcentral.com/articles/10.1186/s13058-019-1210-4#Tab1 10-20% ORR 4-6months ...more  
Comment by scarlet1967 on Jan 14, 2021 1:09pm
If you go to their website they have a separate section for partnership, they are already in collaboration with few big pharmaceuticals yet this is still posted at the bottom of that section. If you are interested in exploring partnership opportunities with Sutro, contact us at busdev@sutrobio.com
Comment by scarlet1967 on Jan 14, 2021 1:18pm
Of course they can fail one all their R&D programs so can CYDY yet THTX has a market cap of $200 million US vs CYDY's 3 billion! The same applies to all other companies in the NASH and cancer space yet THTX has been discounted heavily compared to the comparable companies. 
Comment by SPCEO1 on Jan 14, 2021 1:40pm
Since amny of us are not familiar with oncology, could yo give us a brief explanation of ORR, DOR and OS. Also, what is the toxicities issue? I am also not sure what you meant when you were referring to the biopsy in NASH as a weakness. All NASH trials involve biopsies, so it is a weakness shared by all NASH companies. 
Comment by scarlet1967 on Jan 14, 2021 1:46pm
This is common for all cancer trials. When used as a clinical endpoint for clinical trials of cancer treatments, this often called the objective response rate (ORR). The FDA definition of ORR is "the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period."   Duration of response, or DoR, is the ...more  
Comment by scarlet1967 on Jan 14, 2021 1:55pm
Again common term used for all cancer programs. Toxicity grading scales provide consistency in reporting, and provide a framework for assessment and documentation of adverse effects. Objective assessment of the impact of treatment may inform the need for adjustments to the treatment plan. CTCAE (Common Terminology Criteria for Adverse Events) is a list of adverse event (AE) terms commonly ...more  
Comment by SPCEO1 on Jan 14, 2021 2:19pm
Much appreciated! Thanks for that. I have a feeling those terms will become commonplace around here before too much longer.
Comment by Bucknelly21 on Jan 14, 2021 2:23pm
I was thinking today with all the great understanding on this board of all the medical implications ect to the pipeline where has it gotten anyone that's already here? Those who understand it all are already in just a thought 
Comment by qwerty22 on Jan 14, 2021 5:35pm
RECIST is the standardized protocol/rules of cancer studies, it's mentioned on thtx's clinicaltrials page. The wiki entry is a great place to start but there are many good guides to understand RECIST. I think it's worth getting familiar with it and familiar with how other companies report it because there are right and wrong ways to report this data and any company that starts to stray ...more  
Comment by qwerty22 on Jan 14, 2021 6:13pm
WRT NASH I'm just saying what I always say. Thtx doesn't have enough biopsy data in its target population for Ph3. If the markets are fixated on that aspect then it's a big weakness. Assuming the RBC guy isn't playing games and isn't an idiot then my best explanation is he can't get past the lack of biopsy data. As Wino said recently if that's the case, and there is no ...more  
Comment by qwerty22 on Jan 14, 2021 6:25pm
Another way to look at this. Loomba is AHEAD of the regulator. Loomba wants to take the regulators to where his science tells him things should be. That may happen (maybe it should happen) soon, in 6 months, 12 months, before THTX trial readout. The analyst don't want to be ahead of the regulators, they want to be in step with the regulators in their analysis and advise to clients. If the ...more  
Comment by scarlet1967 on Jan 14, 2021 7:51pm
I believe classing standard protocols(terminology) conducting a cancer trial as weakness is not a balanced view as for NASH it seems even the EMA rejected their protocol they still will go a head with the trial in the US where the drugs are priced higher than Europe thus still a massive financial opportunity. Listen if they had both drugs approved the SP would be 30, 40 or 50 fold higher than ...more  
Comment by Wino115 on Jan 14, 2021 8:40pm
Makes sense as we've all heard similar issues from the likes of Steven Harrison the NASH investigator and KOL. His discussion at the conference THTX presented at was insightful and made it clear the guidelines from 3-4 years ago will be modified in many ways -- endpoints, data needs, trial designs and powering, lipids, diabetic effects, etc...Maybe with more clarity there we'll see more ...more  
Comment by scarlet1967 on Jan 14, 2021 9:01pm
The probability they are giving to both protocols is zero atm while other phase 1,2 ,3 biotech trials get credit for their programs.
Comment by Wino115 on Jan 14, 2021 2:32pm
Whats interesting is that the Pacitaxil trial had one of the highest response rates and durations. So if TH-1902 just improves upon that, like they are essentially trying to do, it would be quite a bit higher than everything on that chart for response and duration.  Just meeting the pacitaxil but being way safer would actully be a solid success and take a large market away from other taxil ...more  
Comment by juniper88 on Jan 14, 2021 3:01pm
From an investment point of view getting to those stats would look great.  Eventually the drug might go on the market and give patients less side effects and a few extra months of OS. But from a patient's point of view (my wife started 3rd line chemo this week for her 2nd ovarian cancer recurrence), we are hoping for more.  I am interested in seeing actual Complete Responses,  ...more  
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