Theratechnologies Inc T.TH

RE:RE:RE:RE:RE:RE:RE:Credit Suisse event now available

[scarlet1967]

The HIV market is much smaller and I am not sure how much cheaper or smaller that trial would be? I also think the company wants operations  outside the HIV market.

• Approximately 1.2 million people in the U.S. have HIV. About 13 percent of them don’t know it and need testing.
• HIV continues to have a disproportionate impact on certain populations, particularly racial and ethnic minorities and gay, bisexual, and other men who have sex with men.
• In 2019, an estimated 34,800 new HIV infections occurred in the United States.
• New HIV infections declined 8% from 37,800 in 2015 to 34,800 in 2019, after a period of general stability.
• In 2019, 36,801 people received an HIV diagnosis in the U.S. and 6 dependent areas—an overall 9% decrease compared with 2015.

palinc2000 wrote: The inial request to FDA was to initiate a Phase 3 tril in Nash exclusively  for PLWH and  that was obviously rejected by FDA and subsequently THTX announced that it was going for the General Nash population

jeffm34 wrote:

Exactly! Why waste 6 years and $100M or so chasing NASH in the general population when you could be focusing that money and effort on a significant NASH market with an already approved drug. 

 

scarlet1967 wrote:

 

 

https://www.clinicaloptions.com/hiv/programs/2021/hiv-and-nash/podcast
 

 

jeffm34 wrote:

 

Why aren't they going after the NASH market in the HIV population right now. They should be out there talking to physicians and direct to patient marketing showing that treating the lipodystrophy can prevent NASH. Yes there are some legalities with what can be said but there are still ways to do it. 

 

SPCEO1 wrote:

On NASH, Paul has made it clear it is his desire to start the phase III in early 2022. He said they are looking into alternative and shareholder responsible ways to finance that. And I get the impression he is very serious about getting this trial started (as he logically should be absent  the potential financial consequences of financing it badly). I believe they a re hoping for some positive info coming from the MDGL NAFLD trial that is due to report out results shortly to help get potential partners interested in NASH again. I am not sure that will work but it is worth waiting for to see. If not, he goes to the alternate approach and moves forward with the first 400 patients, funding it piecemeal as they go by leveraging the commercial operations of Egrifta and Trogarzo, which I read as accounts recievable financing but it may be something else. 
  
 

 

qwerty22 wrote:

So it's pretty clear now that the part1 protocol is different to the way they previously presented it (Scarlett was bang on). So enrolment numbers are still very low. I think I'm a little more comfortable about there being no efficacy signal so far. Once you combine the low patient numbers, all-comers, low doses and super sick people then it's perfectly acceptable to not have a signal so far. The pain for us has been the time it has taken to get to this point, I think the impression was we'd get to this point faster than we actually have. So for me the good news is they have gotten to this point in as good a shape as you might expect from a safety perspective and if there is going to be a first sign of efficacy then is was probably always weighted to happen from this point forward so the lack of efficacy so far is not too much of an indicator of what might happen in the weeks/months to come. 

Like SPCEO I wish they'd be more open about some of the things they've seen in the patients so far. If they are presenting the mouse data for drug breakdown in the blood. And they say they have early human data for that as well and both align. Why not flesh that out a little. If the amount of free docetaxel is very low then some sort of provisional peak number would be super encouraging.

I think I parse Paul's positivity as arriving at this point is the trial in as good a shape as you might hope for. The potential for efficacy  (if it's coming) is still ahead of us. 

Along the lines of SPCEO's grading it's -

B- for the state of play so far (it would be higher is they shared more actual human data)
D for the length of time it took to get here.

Just on NASH

Sounds to me like time (and waiting) is going to be another important factor in advancing NASH P3. I don't expect anything until later in 2022. Sounds like they are seeing many in the NASH space are in a wait and see mode. If the wait drags on it won't simply be due to the internal strengths/weaknessses of the program alone.
 

 

palinc2000 wrote: Under event tab at Thtx website