Theratechnologies Inc T.TH

MTD

[juniper88]

A couple of question for those who might know more about this.

1) If MTD is reached then is the company obligated to announce it?  What have other companies done?

2) If yes for 1) then is there a time lag between reaching MTD and the announcement.  For example, let's say a patient had toxicity on Aug 1 then by what date would it be confirmed that this is MTD?

It looks like another month (aug) has gone by without MTD being reached.  But my paranoia nags at me wondering if MTD could have been reached but just not announce or confirmed yet.

[qwerty22]

It's difficult from the outside to know exactly what triggers an announcement but generally it seems to me companies like to announce a set of data, so MTD, toxicities and efficacy. So I don't think companies are obligated to announce MTD as soon as it's reached. MTD can be thought of as a stand alone thing but it makes more sense when you know the doses an efficacy signal is kicking

[juniper88]

Thanks, yes that helps a lot.

[stockman75]

Yes thanks for the Q&A. I had been wondering how this worked as well. It seeems like the board in general (many here) have been assuming we haven't yet hit MTD. But that is an assumption not necessarily true.

[SPCEO1]

I have been assuming the trial is ongoing and that they would likely have to announce if it had ended, but Qwerty no doubt is correct that this is not the case. However, Paul's effusive comments on the Canaccord Growth Stock conference call are a good hint that the trial was ongoing at that time. Now, he could have been effusive because even though the trial may have  stopped, (I really

[palinc2000]

Are patients in the trial told if their tumor is shrinking and if so are the patients prevented from spreading the good news?

[Wino115]

If/when they reach the dose where intolerable SAEs hit, they back up one dose and do a full run of 6 patients with that.  Then it sounded like Marsolais said at the KOL call that they would monitor any efficacy signals for 3 months to make sure they are significant, and then discuss it.  So they sound like they will take the full time allotted before starting 1b. My assumption is

[qwerty22]

At some point they will stop enrolling new patients in part 1 when they reach their top dose but patients on the trial keep getting doses as long as there isn't a terrible safety issue or they all just progress with their disease because the drug is completely useless. I don't think the trial formally ends for a very long time, if it did it would be for terrible reasons. So MTD is pretty

[jfm1330]

You are right with Paul effusiveness during the last chat, remember his "extremely excited" related to oncology. That being said, I will remind, once again, that toxicity of docetaxel is related to the concentration in the bloodstream, and that at that they follow that after every injection at many time points. By now they know the pharmacokinetic profile of TH1902 in humans, and they

[SPCEO1]

On the issue of when they will report out the trial results, this is what I have consistently heard from TH. First, they will report safety and preliminary efficacy data sometime in Q4 and that they hope to identify the MTD by the end of the year. So, what I hear is that we will get some early indication fo the trial's results but the full blown report on it will not come until near the very

[jfm1330]

If the phase Ia is over before the end of 2021, I expect the phase Ib to start before the end of February and forget about late April. Only very disapointing results would lead to that. Again, they already know now, approximatively, how the phase Ia will end in terms of toxicity, and they likely have the first signs of efficacy. So they will not end phase Ia and only then start analyzing and

[qwerty22]

I think they have the data in their pocket by October and Paul gets to brag about beating the timeline again. But safer to go with the company's guidance.