RE:RE:Enough on Trogarzo/Rukobia - Back to what matters - TH-1902 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 soon or later end up with lipodystrophy so again the MDR market might be shrinking but the lipo will only grow not to mention other not confirmed therapeutic benefits of the drug which currently have been investigated in various clinical trials such as:
“Body Composition and Adipose Tissue in HIV patients (which can contribute to the increased cardiovascular risk), Tesamorelin to Improve Functional Outcomes After Peripheral Nerve Injury (which allow for faster and greater recovery of motor and sensory function following surgical repair of injured peripheral nerves), Tesamorelin for Cognition in Aging HIV-Infected Persons(as HIV infection can result in memory and thinking difficulties in some people, even those successfully treated with antiretroviral medications Tesamorelin can significantly improve memory and thinking in HIV) least and not last Growth Hormone Releasing Hormone Analog to Improve Nonalcoholic Fatty Liver Disease and Associated Cardiovascular Risk.”
Each of these conditions if confirmed to have beneficial therapeutic effect by Tesamorelin separately and in synergy with lipodystrophy can present a financial opportunity for the commercialization of the drug.
As for Trogarzo it seems like the long lasting injectable drugs have their own market otherwise companies like Gilead, Merck GlaxoSmithKline etc. would not allocate resources towards those projects also Doctors should be aware of waiting to the last minute (failed regime) is a dangerous game plan as the increased viral load could easily lead to infections and AIDS. So once the IV push/IM are launched it is reasonable to expect a moderate sale growth for Trogarzo from these very depressed levels.
As for NASH I can write a book about all MOAs of the drug and yes in my opinion it is a real opportunity although the industry is in induced coma atm never the less it is an epidemic unmet condition with huge financial prospects for more than one to be approved drug.
Now the most popular project among THTX’s investors the oncology program, it is worth to remember the early safety/efficacy results although if good are encouraging specifically they are coming from all comers (unknown sortilin concentration) there are still the results from a few patients. It is encouraging as if any of those patients show proof of concepts with low concentration of the receptor that means firstly good affinity, secondly the drug does what t supposed to do and lower off target delivery among others, I think it is well too early to celebrate the good results or throw the towel in due to lack of results because the real statistically relevant test is a head of the protocol on larger number of patients with known sortilin levels. Now they know much more than we and based on their findings so far so they made some changes to the basket trial in order to maximize the chances of the program so if I wanted to speculate I would guess so far so good!!
I guess what I am trying to say is the job for the IR department of this company is to make it clear they have good shots on both increasing revenues and the there are great financial prospects for their R&D projects. Perhaps the last point is what matters most!?
Wino115 wrote: 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 the uncertainty around all this. Seems reasonable to me.
SPCEO1 wrote: 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.