Theratechnologies Inc T.TH

Speculating about the Protocol

[SPCEO1]

I suspect it is going to be pretty quiet around THTX until after Labor Day in the US. The Canaccord presentation yesterday clearly did not lead to a surge in institutional buy orders today for the stock (although there can be a delayed reaction to such presentations as analysts need to go back and do some work on a new idea like THTX) so there may not be any excitement coming from that. The only other news of note is that Canaccord has put itself up for sale and that may mean Ed Nash is busy cleaning up his resume. If he has not been paid some retention bonus while the owners of Canaccord negotiate any deal that may arise, he may want to take matters into his own hands and look for another job before any deal forces the issue on him. Now, if he got a job elsewhere, my guess is his relationship with TH and the possibility of a deal on the horizon would pretty much guarantee he picked up coverage of it quickly. So, nothing may be really lost if he did leave Canaccord as long as he joined another broker in a timely fashion.

So, we have some time to predict as best we can what the protocol might look like before it is announced. We know for sure that it is going to be a HIV NASH trial, so the NAFLD angle is not an issue worth talking about.  The next big question is whether it will be a pivotal trial, meaning they can apply for approval upon its successful completion. It seemed to me that Dubuc hinted that would be the case yesterday, but we cannot assume 100% certainty on that. Many will remember the much earlier discussions about the possibility of a phase IIb/III trial and I suspect that could be still technically referred to as a pivotal trial.    

Now, I, at least, do not have much to base any predictions on as I am not a scientist and am not well acquainted with the issues the regulators are likely to view as key in the phase III HIV NASH trial. Additionally, this is the first HIV NASH trial ever, so we have no historical precedence to guide us. In many cases, what seem to be minor details in a trial protocol can have an unusually alrge impact on the ability of the drug to succeed in the trial and/or be successful in its market once it gets approved. Our chances of anticipating such details are not high.

But, it is worth a try anyway so here goes my first attempt at guessing some of the major aspects of the protocol:

1.) It is a straight HIV NASH trial (Admittedly not much of a prediction since Dubuc said so already)

2.) It is a straight phase III trial - no phase IIB 

3.) Endpoint 1 - NASH resolution

4.) Endpoint 2 - Stabilization of liver fibrosis

5.) Trial size - 400 patients

6.) Trial cost - $45 million (bigger trial, covid issues raise cost)

7.) Trial duration -  3.5 years (more time to recruit since a larger number of patients, covid issues)

8.) Liver biopsies required at start and finish

9.) The Grinspoon patent plays some significant role in this trial

Those are all just the basics. I have to believe there might be some other angle in this trial that will make it more interesting, perhaps revolving around Dr. Grinspoon's mysterious patent. Dubuc seemed very confident during the protocol talk yesterday with Canaccord, even if he revealed almost nothing of note, and I have sensed confidence generally from management recently. I think they know they have something good but I am not sure exactly why. The limitations of the phase II trial and the natural questions that arise from that (as Qwerty has noted in the past) seem like they are not weighing the ccompany down at all. So, they must ahve come away from the harmonization and negotiation process with the regulators about the protocol plan feeling pretty good about what they were able to achieve. Anyway, that is all just impressions and could be wrong. Above is my first, unscientific shot at it and I welcome feedback and other guesses from those of you who are better suited to be making such predictions.

[Bucknelly21]

I think that's a good baseline, I am surprised that no one has asked them anymore about the general nash since that seems to still be on the table. And as far as being quiet till September, we all now it's pretty quiet here all the time lol 

[longterm56]

While we're speculating .... exactly what are they waiting for?  Are they still awaiting approval from the agencies? Waiting on a big pharma to finalize partnering deals?  Waiting on analysts to get back from vacation?  Waiting for patents to be confirmed?  ... just what is it that was expected to happen "mid year" and is now "a couple of months"

[qwerty22]

It's hard to know. Given the Board gave this project the green light 15 months ago, given the direct clinical data was out 15 months ago. You'd think they'd OD'ed on waiting by now. If Philip says they are working to accommodate both regulators then the two regulators mustn't be on the same page. If they have to take advise from KOLs then it can't be that obvious a

[SPCEO1]

My best guess is the confidence being displayed by management indicates the harmonization process has been completed satisfactorily and the company is just waiting for the final minutes of the understanding reached about the nature of trial. Until a company receives that confirmation, they are hesitant to speak specifically about what has been agreed upon. There clearly were sticky issues to deal

[qwerty22]

I just don't think they are at the stage you think they are at. Ed Nash directly asked Philip if they were just waiting for minutes and Philip's response was. "we want to be sure we have a program that is acceptable to both agencies.. and so we're getting closer to be able to announce it" Why would you continue to talk about trying to accommodate two positions if you

[palinc2000]

It is obvious to that describing the outstanding issues with FDa and Ema on Nash in the March 30 PR as harmonization issues was a misnomer and overly simplistic ..... I am of the opinion that the lack of openness is only becsuse they dont want to be sued for misleading past comments. But in the grand scheme of things there will be  imo a pivotal Phase 3 trial ..... with achievable end points