Theratechnologies Inc T.TH

RE:RE:RE:RE:I would like to see TH endorse NASH

[qwerty22]

I agree, when they choose TO apply to the FDA and NOT apply to the EMA they understood where they where with the regulators so let's assume they also understood the FDA letter wasn't going to be the final hurdle. They understand they have a complex process.

SPCEO's observation that there has been a rapid change of pace on NASH messaging looks like a reasonable one but as you said it's unlikely anything material has prompted that. So has the messaging switch come for negative reasons or positive reasons?

I think SPCEO might be doing what he warns everybody else not to do, worrying as we get closer to the decision point.

It's possible the strong messaging on NASH before Christmas is the aberrant thing here, them trying to get promotional to support the financing, now we've gone back to the normal. It could be they positively want to promote cancer with a clear message, it could be they are in negotiations over the future of the NASH program with more than just the regulators. It could be many reason.

The only thing clear is SPCEO has joined the Nervous Nelly camp :)

palinc2000 wrote: The Closing of the Offering is just 3 weeks old....The thought that they might not proceed with Nash in a Phase 3 trial is unimaginable unless  bad new data came to light in the last 3 weeks and they would have to disclose that without delay,,,,They maybe a lot of things but they are not crooks
 

scarlet1967 wrote:

I would like to them to endorse everything more often. They did mention NASH even at Fireside chat, they just diluted and raised more money than they would need in near future if they only wanted to go ahead with oncology, they might not even needed to raise cash at the low ball price. NASH is a big money maker and they will be a phase 3 NASH company even if they need to drop Europe, theoretically the success rate for NASH is much higher than oncology so why drop it after that letter?
I think going forward they will be endorsing NASH but in the midst of negotiations with both agencies they might keep a low profile. This part below just turned up on their website, I don't recall it was there! Note they see themselves as a R&D company in hepatology also they mentioned both agency later on as we know the oncology is not trialed in the Europe.

Expanded Access Policy

Theratechnologies Inc. (“Theratechnologies”) is a biopharmaceutical company focused on thedevelopment and commercialization of innovative therapies. Our commercialized products and our research pipeline focus on specialized therapies addressing unmet medical needs in HIV, oncology and hepatology. Theratechnologies has begun development of the SORT1+ Technology™, a novel and targeted treatment platform in oncology based on new proprietary peptides targeting sortilin receptor (SORT1). The first peptide-drug conjugate (PDC) generatedfrom this platform, named TH1902, is under investigational evaluation in a Phase 1 clinical trial for the treatment of patients with recurrent advanced solid tumors (i.e. triple negative breast cancer, gynecological cancer, colorectal cancer, and pancreatic cancer) that have relapsed or are refractory to standard chemotherapy, surgery, radiation therapy, and for which no knowneffective therapies exist (ClinicalTrials.gov Identifier: NCT04706962).

Theratechnologies believes that investigational drugs should be primarily studied within clinical trials designed to obtain data on safety and efficacy about the investigational drug. The data from these trials may then ultimately be used to support approval of the product by regulatory agencies such as the FDA in the United States, the European Medicines Agency in Europe and Health Canada in Canada. The approval by regulatory agencies enables patients to have access to the medicine. Regulators will only authorize a new medicine if the results obtained from these clinical trials, together with other research data, demonstrate that a medicine has a favorable risk/benefit profile when used in a defined and controlled clinical setting. We encourage patients to speak with their physicians and to participate in clinical trials, when appropriate and if eligible.

As a general policy, Theratechnologies will not provide an investigational drug product until there is sufficient clinical data available from its existing clinical trial(s) to identify anappropriate dose and to evaluate preliminary safety and efficacy information to make a risk/benefit analysis consistent with the establishment of an expanded access program. This is typically not expected to occur earlier than after completion of Phase 2 studies and afterconsultation with regulatory agencies. At such a time, Theratechnologies will disclose the criteria pursuant to which expanded access requests will be assessed. Given the early stage of the clinical development of TH1902, Theratechnologies’ investigational drug product is currently not available for expanded access.

If you are a patient who is interested in receiving TH1902, please consult your physician. You may also learn more about the ongoing clinical trial by visiting www.clinicaltrials.gov and searching for the clinical trial identified NCT04706962.

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In line with the U.S. 21 st  Century Cures Act, Theratechnologies Inc. may revise this expanded access policy at any time and the posting of this policy by Theratechnologies Inc. shall not be construed as a guarantee to patients of accessing any specific investigational drug.