Theratechnologies Inc T.TH

Enough on Trogarzo/Rukobia - Back to what matters - TH-1902

[SPCEO1]

So, we had a small chance of hearing something this week about preliminary efficacy seen with TH-1902 based on a number of assumptions which we cannot be sure were even accurate (since the company is not commenting on those assumptions). Here are the assumptions"

1.) At least one of the first three patients at the 300mg dosage level had their first six week scan on May 9th, which meant the phase 1b portion of the trial had begun. It is possible more than one had a scan that day, and as many as all three did, but it seems more likely the three were spread out over a number of days. It is entirely possible this assumption is inaccurate but I did hear at some point that TH did expect some patients to roll over from the 1a into the 1b. TH had said the 1b would get started towards the end May (or maybe by the end of May - can't remember the exact wording) so it seems that with the phase 1b starting on May 9th (I am assuming it started May 9th and  was announced May 10th). that likley indicates a scan on one of those first three 300mg patients was done on May 9th.  

2.) If the first scan on the first patient was on May 9th, the second scan would have been scheduled on June 20th. If that scan confirmed at least 20% tumor regression, then it is my understanding that  TH would have had to announce that by last Tuesday. Since there was no announcement, then we can assume there was nothing to announce for patient number 1. It is worth noting these are very sick patients and one who showed signs of preliminary efficacy at six weeks is not guaranteed to be healthy enough to continue the trial over the next six weeks. Also, I wonder if preliminary efficacy is shown how these things are stage managed behind the scenes. Do the investigators give TH a call and say "Hooray! We have preliminary efficacy confirmed in patient X" but protocol says that until TH receives written confirmation of such, it is not official, thereby giving TH a little more time to get its ducks in a row before the offciial announcement? Maybe.

3.) Even if the first patient scanned on May 9th (assuming that is accurate) did not show signs of preliminary accuracy, what about the other two patients who first recieved that dosage? Either one of those two could have rolled into the 1b with a slight delay, probably no more than a week or so. If so, the window for getting very fortunate and hearing about any preliminary signs of efficacy early in the 1b is likely open until Wednesday of next week. If all three early patients rolled into the 1b, we have a 1 in 3 chance of hearing some early success. Those are not great odds but they are better than nothing.  

4.) If we have not heard anything by next Thursday, it is probably safe to assume we went 0 for three on the first three. Then we have another 1 in three chance with the second three patients who enrolled at the 300mg dosage level coming up two weeks after that on July 11th , again assuming that all three rolled into the 1b and remained healthy enough to continue with the trial, which may not be the case, and got their first scan around May 30th. Again, it is unlikely all three of this second round of 300mg patients got their first treatment on the same day so we could hear results from them in roughly the week after July 11th. 

If instead, the first 1b patient was actually enrolled on May 10th and they had not been treated with any doses in the 1a portion of the trial, then the first six week scan occurred last Monday and the second confirmatory scan will happpen on August 1st. Depending on how fast the trial intially enrolled will determine what happens from that point forward but It seems fair to assume the chances of seeing a patient who meets the criteria of a preliminary signal of efficacy improves as the month of August continues and really picks up a lot in September. If September ends and we have not had any preliminary efficacy signals, then one has to start being concerned the drug is not working as there likely would have been many shots on goal by then one would expect some scores in the early going. 

Clearly, if the trial is to end in March, than enrollment should be complete by December. If patients were added evenly throughout the months heading up to December then about 10 per month would be added, but I suspect it doesn't work like that. If the phase 1a results have encouraged the investigators at the current sites, I suspect there would be some patients lined up and ready to go when the phase 1b started. Then there might be a lull until other sites are brought on. Europe is supposed to come on in July and other sites in the US are also supposed to open although we have not seen or heard of any indication of new sites in the US so far. 

So let's presume we have a total of 20 patients that will be able to have ther sceond scan by the end of September or sooner (clearly at least six will occur between now and mid-July if all the first six 300mg patients in the 1a rolled over). If we have not seen success in at least one of those estimated first 20 patients, then it seems reasonable to begin to worry about the effectiveness of TH-1902 as September comes to a close. Now, there would still be 50-55 more patients to test, so all hope would not be lost, but the odds of seeing success in those 50-55 will drop considerably from my perspective if we have not seen success in the first 20 patients. 

Clearly, if we have not heard any reports of preliminary signs of efficacy by the time TH announces Q2 financial results, it will be interesting to see how they describe the situation during the conference call. The company will no doubt have access to the first scans of a number of patients by then and will know how things are trending. 

Here's hoping we get an announcement of preliminary efficacy tomorrow or next week so the summer wait will not be difficult. Additionally, if TH is successful on one or more of the first three patients, that tells us TH-1902 might be pretty potent and could portend much greater success further down the road.

[Wino115]

These are the kind of clarification questions they should get and likely WILL get on the next call in July, so hopefully IR and management are alerted and have clear and substantive facts around the varioius issues to discuss and talk about.  Just simple 1b patient #'s, by type, rough start dates, expected outcome dates, etc... Simple stuff they should know and can discuss to help dispell

[realitycheck4u]

This post has been removed in accordance with Community Policy

[scarlet1967]

This is my take re what matters, in my opinion all of it matters one can argue the immediate positive/negative effects of failure/success or anything in between of the company’s operation but in the long run all of them are crucial to make this company investable. As for sales I believe there is good opportunity for Egrifta’s sales to grow as the aging MDR cohorts on various antiviral regime will

[Jane101]

To SPCEO - Just curious, where did you get these assumptions?  The company never posted anything this detailed?  Unless I missed it do you mind sharing your sources? Also, these guys are a small company.  Looks like this is the type of stuff you would get from a biiger company like Macrogenix over the span of a year, not in 5 weeks. It's kinda long expectations and so much

[SPCEO1]

Those assumptions are just me putting together the puzzle pieces as best I can from the few facts we have, as well as tidbits of info picked up here and there. But they are assumptions and therefore are most definitely inaccurrate in whole or in part. The only things we know for sure is the phase 1b trial started on May 10th and that the trial protocols call for scans of the tumors to be done at

[Jane101]

SPCE ok thanks - it's a really really detailed analysis so one can't help but wonder where you got it from?  I read you are a professional investor too, do many portfolios management  talk on message boards? is that ok?   I am happy with what I see so far with THTX , but i bought it at 2.30 so I am in good shape. How much did you buy and at what price?  

[SPCEO1]

As Lee noted, this message board contains a number of really talented posters, so do not be surprised by insightful information you see here. This message board must be one of the best there is but, since THTX is still relatively unknown, it is pretty far below the radar screen ofalmsot all investors. I began posting here about THTX well over a decade ago when I saw that the nice people here could

[Jane101]

well, there are a lot of short sellers who sit on stock message boards and try to set up expectations that a company cannot ever meet and then profit.  That is a very sneaky-snake thing that happens a lot of the time.  I am new to the story and trying to learn as much as possible, but from your super long messages, I am thinking you don't want the company to succeed...why else would

[SPCEO1]

I will take you at your word thatyou are new. I think if you stick around, and keep reading my and other great posters long messages here, you will find it is all legit. Sorry that you have bad experiences on other boards. Be prepared for a different experience on this excellent board. Also, you can check and confirm that my firm owns around 4 million shares of THTX, so it would be quite odd if I

[Momo25]

He has no source, nor viable information. Just iterative speculation. I am suspecting, he runs a biotech fund and tries to keep TH shareholders as much optimistic as he could. That's it, that's all.

[Wino115]

I know you're an angry skeptic Momo, but your characterization is wrong.  He has stated the various facts the company has mentioned (1b start date, some patients rolling in from 1a, etc...).  Those are all statements of fact from management, not guessing.  He has other info he has gleaned and he is trying to put together a scenario analysis for an investor to think about.  

[Lee430]

We all deserve our opinion of course, personaly I feel that counting Rusty as one of our contributors on this boartd is a huge asset along with some of the other highly talented contributors here....please take the time to find out who Rusty is as his insight took years off my retirement date.....link below to Rusty.   https://www.stewardshippartners.com/about.htm  

[qwerty22]

You're not forced to read anything.