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 > Best Option?

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Comment by qwerty22on Jan 12, 2021 12:21pm

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Post# 32276475

RE:RE:RE:RE:RE:RE:RE:RE:Best Option?

The Covid police came and broke up the party.

SPCEO1 wrote: Pre-offering, it seemed safe to assume that the phase III was a done deal despite that minor wiggling in the PR. And that getting the EMA on board seemed like a lock as well. Now, one has to wonder. Why the desperation to get a really awful deal done? Is there something ahead that would make raising money more difficult? These are logical questions and ones I asked the CFO last night. But I did not get any good answers to those questions that would shed any additional light on the matter. So, it now remains an open issue for us to fret about in the months ahead until an annuncement on the final protocol structure is made.

qwerty22 wrote:
Here's my next worry. Given they are getting cash in the bank early is there any chance the RBC guy is right and the wrinkles still to iron out with the Ph3 are substantial? It seems a stretch given the content of the PR but there's some wiggle room (I know there's always wiggle room).

The Company announced today that it has received a “Study May Proceed” letter from the FDA for the Phase 3 trial with a recommendation that the Company requests a meeting to discuss questions and comments received on certain aspects of the proposed trial design, to ensure alignment with the agency’s expectations with NASH trials.

Can that mean it's provisional on the discussions? It would clearly say that right?

The final timing of the trial initiation is dependent upon any adjustments to the protocol and trial design as recommended by the FDA and European agencies.

This just looks like standard wiggle.

It really makes no sense for the FDA to say "study may proceed" and 3 months later add "after you do a Ph2, right?