I think it's hard to know for sure exactly what each of the 43 are out of the trial for. The fact that they submitted a rollover for 12 patients tells me (just a guess) that they saw a number of patients progressing to where they'd be eligible for it. Maybe there was 10 and a couple they were unsure about, so they submit for 12? But my point is that if 12 are rolling over, that leaves 31 to further decipher, because I believe if more needed to roll over they'd have gladly let them. It's another way in which LL is going to prove itself so they wouldn't pass up on letting more than 12 roll over.
There are often people who leave trials for reasons that are really unrelated to the study drug. There can be other issues that creep up and cause someone to either become ineligible or they need to leave to be able to do something else. It can be positive for them or negative, and we don't know how many of those have occurred, if any at all.
In fact, one of the frustrating things about people taking medications is that they often stop when they feel better because they think that's all they need. It happens with blood pressure meds. Once the blood pressure looks good there are people who think they can stop know because it's fixed. It happens with antibiotics, which are dosed based on the time/quantity needed to fully clear/kill the bacterial infection. If you feel better but have four days left and stop, you're likely going to get sick again. I'm hopeful that these patients are smarter and more desperate than someone not battling cancer, but you never know.
Another subset of that 43 will likely have, unfortunately, passed away. Like Jay or Kasi said at one point, these are basically patients whose next step is hospice. They're very sick. And similar to what we saw with the sickest of the sick during covid, specifically Dr. Seethamraju's patients, there can be a strong initial biomarker/immune response that just can't overcome the fact that the patient has progressed too far to be saved. We also see a few low responders to ctdna drops in the slides because not every drug will work for every person. There are people with allergies who have tried Zyrtec and it doesn't work hardly at all, but Allegra does great. And vice versa. These drugs should cause the same basic reaction in every body but it just doesn't always work out that way in real life.
And what about patients who have made it a year already? Are they counted as not in the trial now? I don't know if that's the case, but if so there are some who wouldn't be actively in the trial any longer and could be part of that 43.
I guess what I'm saying is we really don't know exactly what happened to each of the patients no longer in the trial. Some may not have a need or a chance to rollover.
What we do know is that the company believes they have the goods to beat the standard of care, and are seeing a lot of anecdotal evidence that LL is making a difference (less pain, getting back to work, Kasi immediately decides to start working on a new trial). And that's after all they've seen. They know how this thing is going and all the ways in which it's going to open eyes. That they continue to show confidence and eagerness to get this data out is a massive tell.
There are often people who leave trials for reasons that are really unrelated to the study drug. There can be other issues that creep up and cause someone to either become ineligible or they need to leave to be able to do something else. It can be positive for them or negative, and we don't know how many of those have occurred, if any at all.
In fact, one of the frustrating things about people taking medications is that they often stop when they feel better because they think that's all they need. It happens with blood pressure meds. Once the blood pressure looks good there are people who think they can stop know because it's fixed. It happens with antibiotics, which are dosed based on the time/quantity needed to fully clear/kill the bacterial infection. If you feel better but have four days left and stop, you're likely going to get sick again. I'm hopeful that these patients are smarter and more desperate than someone not battling cancer, but you never know.
Another subset of that 43 will likely have, unfortunately, passed away. Like Jay or Kasi said at one point, these are basically patients whose next step is hospice. They're very sick. And similar to what we saw with the sickest of the sick during covid, specifically Dr. Seethamraju's patients, there can be a strong initial biomarker/immune response that just can't overcome the fact that the patient has progressed too far to be saved. We also see a few low responders to ctdna drops in the slides because not every drug will work for every person. There are people with allergies who have tried Zyrtec and it doesn't work hardly at all, but Allegra does great. And vice versa. These drugs should cause the same basic reaction in every body but it just doesn't always work out that way in real life.
And what about patients who have made it a year already? Are they counted as not in the trial now? I don't know if that's the case, but if so there are some who wouldn't be actively in the trial any longer and could be part of that 43.
I guess what I'm saying is we really don't know exactly what happened to each of the patients no longer in the trial. Some may not have a need or a chance to rollover.
What we do know is that the company believes they have the goods to beat the standard of care, and are seeing a lot of anecdotal evidence that LL is making a difference (less pain, getting back to work, Kasi immediately decides to start working on a new trial). And that's after all they've seen. They know how this thing is going and all the ways in which it's going to open eyes. That they continue to show confidence and eagerness to get this data out is a massive tell.
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