RE:RE:RE:RE:RE:RE:Rebranding the Sort1As I wrote yesterday, it seems FDA does not want them to use it as an enrollment criteria. The biopsies are done to see if there is a correlation between efficacy and sortilin overexpression. In other words, the FDA wants negative control in the study. I don't see the point of that. It's an hypocritecal way to enroll patients that are not overexpressing sortilin, because if you would say to a patient, you don't overexpress sortilin, do you want to enter a trial and take this drug aimed at sortilin? The unanimous answer would be no. As I said, it's ethically questionnable. One chance out of four to not be suitable for the trial is not a marginal probability.
SPCEO1 wrote: If they are doing biopsies before starting treatments, what might be the purpose of those if not to determine sortilin overexpression. Why have they never talked about them before and what that info is used for? As pointed out by someone else earlier, the FDA specifically did not want to prescreen for Sortilin, maybe to see if all patients had some resposne because of free docetaxel?
jfm1330 wrote: They told us yesterday that in ovarian cancer, 75% of patients are overexpressing sortilin, so 25% are not. So statistically, it's at least one non responder just at enrollment, and if unlucky, it's easily two. That's the problem with this silly idea of not selecting patients on sortilin expression. I still don't get the idea and it's questionnable ethically.
SPCEO1 wrote: Given they had 5 out of 6 responses with ovarian already, the bar to move the 4 stable disease patients to partial responses does not seem impossibly high given the new dosing strategy. It is defintely late in the game financially for THTX but, as you indicate, it may not be too late.
If they were to get much better results this time around, they could raise funds from the market to keep at least a portion of the sort1+ platform themselves but to fully exploit it once it is shown to work, they should probably partner a large part of it. If the drug works, the number of directions testing could go is numerous and they could not handle that in a timely fashion even with a huge influx of new cash.
The Trodelvy scenario is likely off the table now but there are still any number of good scenarios remaining for the stock.
jfm1330 wrote: There is no magical solution. It's too late, given the financial situation of the company, to convince the stock market of the potential, unless they would come with five patients out of six with objectve responses after three or four months of treatment at the 200 mg dose next fall. The only realistic hope is a partnership on terms that are not too bad for Thera and that would provide the necessary cash.