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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

Bullboard Posts
Comment by ANALIAS00on Oct 03, 2019 11:44am
106 Views
Post# 30192107

RE:RE:RE:RE:news

RE:RE:RE:RE:news"... so some mystery will remain unless the company chooses to make it all clear for us." Why that ? I also agree that Management do not help themself. That must be the reason why analysts and investors are now ignoring this stock now. At one point I said ok why not letting the number speaks by themself. If trogarzo's sales would have been as high as expected bringning SP up, we would probably accept this kind of "strategy" or "management's style". But now, since couple of months now, they should provide more than just numbers. They should put some personnal words to those numbers, a bit of anthousiam. I wonder how selling team do their pitch to doctors ... TH management should be doing the same with us (analysts and investors). We dont feel their anthousiam. This is enought to slow down our own anthousiam.
SPCEO1 wrote: After looking at the full info that you posted, it seems to me that the data is messy enough to make it somewhat unusable other than saying that it is clear that Trogarzo does a very good job for a high percentage of patients who are in pretty deep trouble when they stareted taking the drug. I am not sure we can get much more than that out of the data and that is not new info to us anyway. 

On the issue of new versus continuing patients in the Bloomberg data and how this might explain it, I don't think it does help much. What is the real problem is the company saying in its presentation that patients are staying on the drug (which suggests to me a much higher rate that 47% or 63&%) and Bloomberg reporting good new patient numbers while also reporting total sales slipping a bit. Also, Taimed's monthly sales numebrs suggest what the company is saying is correct and sales are growing more like you would expect given the rise in new patient numebrs reported on Bloomberg. I suspect we will know more once they report next Tuesday and be better able to solve this puzzle.

Also, in PR announcing the final approval of Trogarzo in Europe, they noted they were already selling  in Europe prior to that under a compassionate care-type program. Those sales are not going to be in Bloomberg's numbers but would be reflected in Taimed's and in the numbers TH reports on Tuesday; But I doubt they will be broken out for us, so some mystery will remain unless the company chooses to make it all clear for us.

  

qwerty22 wrote: Here are the results from IDweek website in a little more detail

"Cohort 2 enrolled 38 patients with a median age of 53 years, mostly male (87%) and white (53%). At Baseline, median VL was 4.7 log10 copies/mL, CD4 cell count was 26 cells/mm3 and overall susceptibility score of 1.

A ≥0.5 log10 decrease in VL from Baseline was achieved in 28 of 37 patients (76%) at Day 7. Of 24 patients who completed the Week 24 visit, 11 (46%) had HIV-1 RNA levels < 50="" copies/ml.="" of="" 17="" patients="" with="" a="" vl="" assessment="" at="" week="" 48,="" 8="" (47%)="" achieved="">< 50="" copies/ml.="" seven="" patients="" did="" not="" have="" a="" week="" 48="" endpoint="" because="" they="" withdrew="" from="" the="" study="" to="" receive="" commercial="" iba.="" at="" both="" timepoints,="" the="" median="" change="" in="" vl="" from="" baseline="" was="" -2.6="">10 copies/mL.


The most frequently reported treatment-emergent adverse events (TEAEs) were diarrhea (24%), headache (21%), and nausea, cough, rash, and fatigue (16% each). No injection site reactions related to IBA were reported. Most events were mild; 9 patients reported Grade ≥3 TEAEs. Two events were fatal (sepsis and cardiac arrest); neither related to IBA. One event of immune reconstitution inflammatory syndrome was reported and considered possibly related to IBA."



First on communication - You can PR this event in advance when the abstract gets accepted, you can put the poster on your website or you can do the bare mininimum and leave people to hunt down extra info themselves. I'm not seeing any real change in communication behaviour. We have to HOPE they are talking to the right people behind the scenes because there's no evidence they have changed their attitude to communicating with the general market.

So this is a new cohort different to the phase 3 people I assume. Still very, very sick people, two died on study and average cd4 cell count still very very low. Non of this really screams 90% efficacy/retention rate. 37 started, 2 died, you could say they had 17+7 still on treatment at 48 weeks. At best they had 15 with undetectable virus if you assume all those that switched to commercial were <50. we="" could="" be="" generous="" and="" drop="" the="" two="" fatalities="" and="" assume="" the="" best="" of="" the="" commercial="">

24/35 made it to week 48 68%
15/35 undetectable virus 43%

Spceo if you plugged those percents into the bloomberg numbers as retention rates do the new patient/ ongoing patient numbers make more sense?

I understand recruitment at the cliniic might (should) be broarder and healthier and so maybe more prone to success but it would be nice to have that confirmed.






FredTheVoice wrote: Here is the news that MUSLIX is refering to:

MONTREAL, Oct. 03, 2019 (GLOBE NEWSWIRE) - Theratechnologies Inc. (Theratechnologies) (TSX: TH) is pleased to announce that new 48-week data from the TMB-311 Extended Study confirms that Trogarzo® (ibalizumab) provides long-lasting viral suppression and a consistent safety profile with the pivotal Phase III study of 24 weeks. The results of the study were presented today at IDWeek ™ in Washington, DC, USA. The results come from the TMB-311 Extended Access Protocol. A total of 38 patients were enrolled in Cohort 2. These patients had a viral load less than 1000 copies / mL, were resistant to at least one antiretroviral of three different classes and had a viral sensitivity to at least one antiretroviral. In Cohort 2 patients, the reduction in viral load at 24 weeks and at 48 weeks was similar. Respectively, 46% and 47% of patients taking Trogarzo®, combined with an Optimized Baseline Treatment (OBT), including at least one functional agent, had their viral load reduced and dropped below 50 copies / mL. In addition, at 24 but also at 48 weeks, the reduction in median viral load was -2.6 log10 copies / mL. This far exceeds the original goal of a reduction? 0.5 log10 copies / mL. Notably, a viral load below 50 copies / mL is considered undetectable and patients can not pass HIV to others.

FTV.






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