Theratechnologies Inc T.TH

Finally listened to call

[qwerty22]

I was going on people reaction here before.

I thought the call was fine apart from no ongoing trial update.

There was one nugget when Christian seems to suggest that all the main cancers in the trial had over 85% Sortilin expression. He seemed to suggest that was what the up and coming microarray poster would say. If that's true then that is great, in fact fantastic. The worry that they are enrolling significant SORT- patients is really off the table now. It also makes screening for Sortilin less of a priority for now. That's great news.

The other good point for me is Christian clear said the protocol going forward is see two responders from upto 10 patients, expand to 25 and then move forward to the next phase if they have the data to support that. 

They obviously made a prior decision not to discuss the ongoing trial. My take is it is hitting that 2 responders from 10 that triggers the next update especially if that triggers a quick expansion to 25. So this is what we should be expecting. Should that have happened by now? I don't think so necessarily. If no one cancer type has aggressively enrolled then they could have a mish mash of results where none of those quite reach that go signal benchmark. I guess we have to accept they aren't going to dribble out results on every responder leading up to that point.

I can sort of even understand why they don't want to talk about enrolment rates. If you say it's slow, then that's a negative. If you say it's fast and aren't releasing details on responders then it looks like the drug is a dud.

I think the one conclusion we can say is the probably haven't hit the go signal yet. I'm not too bothered (yet) about the trial being a dud. I'm putting this down to our expectations being too high about was is possible yet. You sort of have to admire their discipline is saying nothing about the ongoing trial. It sucks but they clearly decided to say nothing and they did it well.

On other things. I thought they contextualized the NASH situation the way I understand it. I also thought they inspired a bit more hope that the Trogarzo management plan could yield some potential benefits (eventually).

[smallcapinv]

Was Sort expression measured with tissue in trial patients or is it simply retrospective data from historical levels expressed and measured elsewhere?  Important to know. 

[qwerty22]

It's from something called microarrays which are a commercially available material. Essential companies prepare slides of tumour material removed, I expect surgically, and they prepare 1000s of them for R&D science. I believe the slides come with details of the disease so one can make detailed conclusions from them. It has nothing to do with their enrolled patients other than it gives a

[PWIB123]

You and Scarlett picked up on the ssame thing I did after I listened to the call myself. It was around the 35 min mark where the lady filling in for Ed Nash started asking questions about the basket trial and when we could expect information on data to be shared.  I thought Christian's comments were extremely positive and provided insight into what his true thoughts were and the best and

[qwerty22]

The other thought that struck me recently which we've ignored given the focus on efficacy is that we are still very early in the process for safety. Only 13 patients in 1a recieved 300/420 mg doses. We really should be considering that the breaks on enrolment aren't off yet from a safety perspective. It's noticeable that they are timelining 10 months for enrolment and there are 10

[palinc2000]

Very helpful and I hope those moaning about incompetent management and kicking the can and all that stupid stuff can use your posts to educate themselves on what an early stage Trial entails especially with a disruptive technology never tested in humans before this Phase 1 triial I think it should be repeated also that based on publically available data in Phase 1 there is absolutely NO guarantee

[Joemare]

When you add countries, it means there's an issue with patient accrual.  So late in the game to involve Canada and the EU is somewhat due to a lack of a) competency in clinical trial mgmt and b)executive leadership. Are they using a CRO to conduct the clinical trial? If not, why not??? If so, fire them.  Use a better one. Tons out there with P.I knowledge They need to get the

[juniper88]

@Joe.  How many people on this board have actual experience with the TH1902 trial?  It is basically me,and maybe Rusty a small amount with his cousin They are expanding into other countries because it is worthwhile doing.  That in itself was a go/no to decision.  I had the discussion with Christian about why Canada was not going to have sites initially.  It has mostly to

[qwerty22]

I'm not say enrolment is going fast or slow. I'm saying it's rate is most likely baked into the protocol. I think we can understand it was in the dose escalation and I can see every reason why it still is based on managing toxicity risk. Your nurses venting their frustration might in fact be a sign of that.

[Joemare]

Paperwork is an issue to conduct clinical trials in Canada??  Come on!!! Canada is not a 3rd world class country regarding clinical trials and Health Canada are not incompetents.... I don't buy it.  Sorry. Patient accrual is a problem.  Otherwise, you just add sites in the USA or have the centres recruit more........... They should get a CRO..... This is R&D  mis

[juniper88]

Actually Canada is a 3rd world class country in regards to clinical trials and yes they are incompetents. My wife was told she had 1 year to life from doctors at Princess Margaret, the top cancer center in Canada.  I took her to Europe to have an operation done that I was told was not possible to be done in Canada.  I know of several other cancer patients who have had to do the same

[bfw]

"The doctors I have spoken to in the different countries that I took my wife all look down on the Canadian doctors and health care system." Honestly, I doubt they look down on the doctors but do believe that they look down on our health care system. There is no doubt that a private health care option opens up different treatments around the world. That being said, Canadian medical

[Joemare]

You write "Patient accrual is a problem".  Do you have any proof of this or are you just making this up like everythig else you write?? Really??? Cough up the numbers to shut me up!  I want to be proven wrong all the way.....I'll be a very happy shareholder making money. I want to be proven wrong. Now, I'm loosing money........That's the issue. 

[juniper88]

You made the accusation and you want me to disprove your accusation??   Realy??? You come up with the numbers to prove your accusation that patient accrual is a problem.  Until you do it is just your assumption. There is nothing I can write to shut someone like you up.

[Wino115]

Ok, I will settle your tiff.  Your both wrong. ;-).  Here is the best explanation, fits with other patterns I have seen in oncology trials, and is the way you plan out a trial once you see a very high probability it will move on to the next phase.  You'll recall that I once posted the average number of sites for trials based on both size of company and phase of trial. I will

[qwerty22]

The other thing is "activating a site" is not something that happens overnight. I don't believe when Christian said they were talking about doing the paperwork that was to solve a problem with recruitment now. As Wino says that's to deal with where the program might be in 3 or 6 months time.  So just as one example of the paperwork necessary. Each hospital site has it'

[SPCEO1]

Maybe they originally said Canada but I don't remember that. I originally remember 6 initial sites in the US wth five additional ones to be added later. I was also origianlly told maybe 6 sites in Europe would be added in the July time frame. Later, if I recall correctly, they were opting out of pursuing the European sites because  of the hassle involved. The first I remember hearing

[realitycheck4u]

This post has been removed in accordance with Community Policy

[SPCEO1]

Remember, Paul said in mid-August at the Cannaccord conference that they could report one, a couple or maybe several pieces of data between then and Christmas? He gave the impression something might possibly be announced quickly. When you consider that comment, how does it fit into the scenario you laid out. And why would he build expectations for a possible early good report in September or

[CreatingApe]

we still have two months before Christmas right? I have to admit hearing Mr. Spceo this distraught has me incredibly nervous . Thank God for qwerty right now.or I don't think I would be able to sleep

[qwerty22]

I can't recall the exact comments if you have them we can discuss. I expect they are sufficiently vague as to have many meanings. I'm still not against them hitting two responders in one cancer before Christmas though. That could still be on the optimistic side. What would we have? 7 patients on-boarded for each cancer. 2 patients at their 3rd scan, 2 more at 2nd, 2 at 1st and one yet to

[SPCEO1]

The "one, a couple or several pieces of data between now and Christmas" is pretty close to what Paul said in mid-August and it was not vague. I have no problem with Paul giving best case scenarios but it would be better for both him and investors if he identified it as such. For example, he could have said at that time, "The phase 1b trial is progressing nicely and we might start

[qwerty22]

It's very funny. They were asked about MDR HIV  population size. Paul chimes in with "There is a significant unmet medical need for that. No question. What is the untapped population? Is it 2,000? Is it 3,000 patients? We're not entirely sure." John Leasure, the commercial guy, says very straightforwardly "Well, we understand the market size, I think fairly well

[scarlet1967]

This is the latest issued guidance from FDA, so the basket trial a sub category of the master protocol may have “a dose finding/safety component” although generally before initiating the protocol the sponsor should have identified the RP2D, later on they talk about having an independent committee overseeing the safety and recommending protocol amendments if necessary. It seems each sub study has