Theratechnologies Inc T.TH

Patient Protocol Questions

[SPCEO1]

Sorry for the tests - just trying to sort out the copying an image issue using the technique wino suggested. 

So, since the first patient died, let's assume the others have lived just for argument's sake. Since we know we have advanced to the 420 level, does that mean that only one patient has recieved drug at the 300 level or did all of the 4 assumed remaining patients advance to the 300 level? If only one patient got a dosage at the 300 level, is that good enough for the FDA? I would think they would want multiple patients to have shown no toxicity at that level before establishing it as the MTD. 

Why did TH use the rpevious slides of this variety that were clearly not what was going on? And how could it take this long to dose just 6 patients overall? Should we be concerned about the seemingly very slow pace of the trial? I am continuously amazed at how drug companies always massively underestimate the time period for a trial to be completed.

Do they have to get to at least 15 patients for the trial to end?

[Wino115]

First, which technique allowed you to get the picture in here?  I've never figured that out.  I"ll let the dosage experts opine on this, but I think Qwerty pointed out that past patients all get increased along with the new ones if they are still viable patients. He guessed there's maybe 3 that made it up to 300 and would be upped to 400 level if that one has no DLT.  

[SPCEO1]

It wasn't easy! First, while the presentation was running, I did a print screen when that slide was up. I then opened that in Microsoft Paint. I then copied it into Word.  I then saved it as a picture. I then opened up IMGUR.com and browsed through my pictures to find it and loaded it up there. I then copiedd the link for the picture into Stockhouse. I then clicked on that link before I

[qwerty22]

I have a very low expectation that biotech execs tell investor the WHOLE truth and the less palatable stuff only comes out when forced. I can't put everything together that's been said in the past and now a make it work without some bending of the truth. I could lay out a few scenarios but they all have a deal of cynicism in them. It could be that the FDA has signalled all along slow

[qwerty22]

I'll share one of my bugbears atm. I'm starting to hate the "in line with animals" line. There is one set of animal data they've gone public with, the mouse R&D data. And there is one set of data that isn't public, the rat toxicology data. I think they hope when they say "in line with animal data" we'll all immediately think mice, which really does

[SPCEO1]

Investors always have to sort through the info any company shares to try to ferret out something that is closer to the truth, the whole truth and nothing but the truth than the "truth" that management carefully curates to create a favorable narrative. It is just a fact of life and it is why this board has been so valuable - there are some really good insights shared by many here. But it

[qwerty22]

I think I'm with you on the bottom line. The ship is still sailing, no disasters yet. If they want the program to be valued they're going to need to provide more than the scant news so far. I appreciate that you step away from the clinical/scientific data to look for corroborating facts. You are right about Rothenberg. It's likely he's part of Paul's network. Why burn that

[longterm56]

What I hear from this then, is that THTX is equivalent to the thousands of other small biotechs who are ALL extremely excited about their pipelines and whose management hints at any optimistic news while possibly withholds the not so positive facts.  So ... why should the market treat THTX any differently?     -LT

[qwerty22]

Nailed it!  They need to disclose more data. They have to be excited if they are presenting at things like the CS event but we still need an efficacy signal.

[jeffm34]

Based on these unrealistic expectations, hopefully there isn't too big a sell off coming. I don't think you understand what the phase 1a portion of the trial is about. 

[qwerty22]

What do you mean? Do you think the trial design means efficacy is impossible at this stage? My expectation is that at some point an enrolled patient will show a response. Now they are at higher doses it might happen in somebody already enrolled, in the next 6 patient or we might need to be patient and wait for part 2. We see in other trials responders in the first dozen patients, we also see

[jeffm34]

Very unlikely you will see a responder in the phase 1a. If there is that's great! Even at the higher doses now you can't see any response if you can't enroll patients who are likely to respond. 

[qwerty22]

"patients who are likely to respond" Definitely an important metric. Christian had 75% of enrolled patients being Sortilin expressors. Hugely optimistic in my view. I'm prepared to bring that down to 33%. Mostly a figure pulled out of thin air. If we had one responder from the first dozen that would only be 8% responder rate. I don't really know how low to go before being

[scarlet1967]

My take is as per the trial description they are using accelerated titration design so dosing one patient at a time until DLT (SAE3) or two patients with SAE2 then they move to groups of patients, as described below based on how many patients if any show DLT they will either increase or decrease the dosing on groups of 3 and 6. The slide suggests the move from single patients happens after SAE2