Theratechnologies Inc T.TH

Alternate Symbol(s): THTX

Healthcare Biotechnology

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. It blocks viral entry into host cells while preserving normal immunologic function. The Company is also investigating an intramuscular method of administration of Trogarzo. 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.

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Theratechnologies Inc > Md Anderson bureaucratic process

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Comment by Lee430on Mar 18, 2021 7:28pm

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Post# 32834945

RE:RE:Md Anderson bureaucratic process

I have family members that live in Houston TX, you would think the sun rises and sets on MD Anderson Hospital system the way they talk about how great that Hospital is and the high level of care they have recieve there.

Wino115 wrote: There is credibility in them choosing MDAnderson and Anderson having the bandwidth and desire to accept it (along with some $$$). It's a credibility booster to the program for them to be doing it. We need that.

qwerty22 wrote:
I was curious what THTX had to go thru to activate a trial (at md Anderson), (I have an inexplicable attraction to bureaucratic processes). Unsurprisingly it's complicated and bureaucratic.

Here is the department that seems to have oversight of the process and the dozens of documents that cover the process.

https://www.mdanderson.org/research/research-resources/office-of-clinical-research-administration/human-research-protection-program.html

Here is a flowchart of the process it goes thru, most of those boxes are ensuring the right things have been entered into the electronic data system (pdol)

[url=https://www.mdanderson.org/content/dam/mdanderson/documents/Research-Centers-&-Institutes/office-of-clinical-research-administration/hrpp-manual/workflow/CIRB_New_Submission_Workflow.pdf][/url]

Seems like the various committees involved in this process meet on a weekly/monthly basis so not too much delay there, I've been involved in this process at other institutions where similar committees meet on a quarterly basis and missing deadlines is painful.

[url=https://www.mdanderson.org/documents/Research-Centers-&-Institutes/office-of-clinical-research-administration/hrpp-manual/workflow/IRB_SRC_Meeting_Calendar.pdf][/url]

The upshot is the process is too complicated for me to be bothered to understand but it seems the PI has been thru this process many times and given everything is electronic and covered by regular meetings it should have a finite timeline. Eventually once activated I guess the trial will appear in md Anderson's searchable database of trials and I plan to keep an eye on that.

https://www.mdanderson.org/patients-family/diagnosis-treatment/clinical-trials.html