You appear to be mixing two different things, and making an assumption that the evidence does not justify.
Direct is primarily targeted at inoperable tumors, therefore removing the tumor first is not an option. Second, various approaches using mature dendritic cells have failed in the past, as they were not able to sufficiently sensitize to the cancer cells . Immature approaches have failed in the past because they were not able to develop a strong enough response after being sensitized. NWBO's entire approach is based on the hypothesis, supported by trials to date, that partially mature cells can split the difference between these two, being sufficiently sensitized to attack the cancer cells, but sufficiently developed that they don't die off before doing so.
Also, the phrase "linear order of magnitude" is nonsensical, because any growth measured as an order of magnitude increase is an example of exponential growth.
Yes, that's how biotech startup dilutions work. We're giving them money to complete their trials, they (hopefully) pay us back, many-fold, when a successful trial sends the share price through the roof.
Anyone who thinks they are going to get approval out of the P1 trial for direct doesn't understand the system. They are proceeding directly into a P2 trial that is more focused on specific cancers and even that is unlikely to produce an early approval. That was written into the study design.
However, PFS and OS from the current standard of care does provide some basis for comparison. It's not perfect, but if the numbers are hugely better than the current best treatment, it will be a strong indicator of function. That might point the way towards early approval, or at least an accelerated PIII trial.
One advantage of mice as a laboratory test subject. You can order thousands of essentially genetically identical ones any time you want. Another advantage, techniques for culturing various cell lines in vitro are well understood. I would guess some combination of these two, along with others I may not know, results in being able to produce more dendritic cells than is possible in less genetically similar larger animals.
It's very likely that the doctor in question is only handling a few patients, so it's it's iffy he could draw statistically valid conclusions. However, there are two possibilities: He could have one or more patients that are responding far better than expectations, which could lead him to conclude that they are receiving the treatment (not statistically valid, but indicative, or he could have had a patient who was receiving the placebo, and then progressed, who was than transferred to the active wing, which I believe is permitted under the trial design.
Alternatively, he could just be enthusiastic on spec, and it doesn't actually mean anything.
"Primary Outcome Measures:
Number of patients with adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]"
That's from the Direct clinical trial listing. That's what we'll see in Q4. As I said, there may be more information included, I'd love it if there was, but I'm not going to count on it. If you don't expect more than they are committed to provide, you tend not to be disappointed.
My understanding is that most people don't end up getting more than one or two courses of chemo, three at the outside, because by that time it is either effective and the cancer is in remission, or the chemo starts doing as much damage as the cancer.
Double check how warrants work. If the investor chooses to exercise the warrant, they still have to pay the face price at the time of exercise. So it's two shares at $4.90 and one potential share at $6.00.
Cancer is never really considered "cured". There is always believed to be a chance of recurrence, even in 10 year or longer survivors. This is especially true when you have a relatively low number of patients that have used a treatment. They can't talk about longer term survival rates, since they have literally only a few patients that have taken the treatment over ten years ago. Maybe its a true cure, maybe its an imperfect cure, maybe it only treats for a certain period of time. Until they have more information, those are open questions.
I'm still pretty happy. I got in at $3.50. Given last weeks increase, I'm still up 40% and the company has the cash to go forward, hopefully all the way through results on the current trials.
The trial is open for all solid tumors. As far as which ones are actually being enrolled, that's an unknown at this point.
He mis-spoke and meant recurrence, not regression. His point being that we've enrolled enough people that the control group, alone, is almost enough to have reached this milestone, meaning that it is at least tentative evidence that the treatment is working.
I'm not sure what study he's talking about either, there wasn't a control group in the PI study, but there was a standard for comparison. They compared their patients against the "standards of care" which means against patients who were receiving the same surgery, same chemo, and so on. They found that there was less than a 0.003% chance that their positive results came from random selection of patients receiving that sort of care.
It is possible that some other factor influenced the results, which is why they are doing the PIII trial, but it's not fair to say that there was no basis for comparison.
Agreed, there's no way this trigger, at this point, is not indicative of at least some improvement due to DCVax.
I think you're being a little free with median progression free as an absolute number. The rate seems to be about 10% surviving past 6 years under SOC. I'll use 20% making it to four years for your group one. I think it's fairly safe to say that the first 33 (your group 1) would be at about that level, so call it 26.4 events if they only recieved SOC. I'm guessing your group two is actually enrollment before June 2012 (not 2013). At about 18 months, 50% of those would still be alive. However if we take the median PFS at 7 months, we can assume that the average progression starts 11 months prior to death. That cuts it to ~30% progression free (really lower, since I'm basing it from the end of that year). That gives another 53.9 progressing before that point. Therefore, we make it at least 80 events at this point just from these first two groups. Obviously without mean and standard deviation data, these numbers are decidedly questionable, and not statistically valid. And they don't even begin to approach any sort of statistical rigor.
That being said, I do believe your numbers are a little high, but I don't fault your conclusion that the fact we are just now seeing sufficient events for the interim analysis strongly indicates that the treatment is having a significant positive effect.
About five scientists published articles to that effect, and they were widely criticized in the scientific community, although unfortunately widely reported in the popular press.
Even then, more articles were actually published on global warming.
Because you are comparing it to a record low last year. It fluctuates annually, and the exact extant is variable, but even this "increase" of yours is still 23% the 1979-2013 average, and a best fit line shows a serious downward trend.
Climatic cycles happen, but the current warming trend is much faster than anything on record, and the link to increasing CO2 in the atmosphere is pretty definitive.