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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 jeffm34on Jan 02, 2022 12:37pm
142 Views
Post# 34277322

RE:RE:RE:Updated time line

RE:RE:RE:Updated time line

I guess you don't know anything about clinical trials.  Just like last year when I said we wouldn't see any initial efficacy data from the phase 1 trial until first quarter 2022 at minimum.  You all said we would see some by the middle of 2021.  

We are still at least a month (or 2) from part 2 starting.

How long do you think it takes to enroll 40 patients?  Throw in what COVID is doing to hospitals right now and all the other experimental treatments competing for those same patients.  4-6 months is not unreasonable to enroll 40 patients. 

What is treatment and follow up time for each patient?  How many cycles will each receive? 3 cycles and follow up would be around 3 months. 

How long do you think it takes to compile and release data from a trial?  2-3 months 

So no, it is not unreasonable to think we won't see the full phase 1 trial results until 2023. 

The company has said they would release individual data points along the way if it looks good but don't expect to see the full trial results for another year and a start date for a 2 year phase 2 trial around mid 2023. 

jfm1330 wrote: Yes, this guy is posting messages with false content. That being said, phase Ia is taking longer than expected, that is clear, but it is false to assume that phase Ib will take as long. Phase Ib will not involve sequential dose escalation. In theory the planned 40 patients could be treated all at the same time with the same dose per body surface area (m2). It will not happen for practical reasons, but it is likely to take much less than a year if enrollment is easy.

 

longterm56 wrote: I think I'll wait to hear from THTX, rather than assume the worst and create fictional schedules without any facts. "Fear, uncertainty, and doubt (often shortened to FUD) is a propaganda tactic used in sales, marketing, public relations, politics, polling and cults. FUD is generally a strategy to influence perception by disseminating negative and dubious or false information and a manifestation of the appeal to fear."
jeffm34 wrote:

According to the clinical trial website the estimated completion date for the phase 1 trial was March 2022.

https://clinicaltrials.gov/ct2/show/NCT04706962

Now we know part 1 should likely be completed by March 2022. Almost 1 year after they started. Part 2 will involve more patients so we can assume it will take as long or more likely longer than part 1.  So now we are looking at least March 2023 to finish the phase 1 trial which means the trial is already a year behind schedule!  


 




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