Um, because no one knew why screening had been halted. And we still don#$%$ obviously not safety, or they would have halted the trial completely. So it's either administrative, or it's something substantive, and if it's substantive and not safety, it's got to be positive (since NWBO wouldn't be filing a halt for futility on it's own initiative).
Because this one is in later stage trials. Has never failed a trial. Oh, and works on all GBM cancers, not a selection with only a narrow range of genetic markers.
Only if your assumption is correct, which you still haven't provided evidence for, or reasoning for, or a trace of logic behind.
Um, if that were the case, it means that more patients, not fewer were enrolled under the original criteria, which is counter to your basic argument. the criteria changes were made in late May or early June, if you're arguing that 25-30 patients were enrolled by then, that puts a minimum of 7-9 B patients on the original criteria (and again, that assumes an A then B format you still haven't produced a single fact to support).
You're still wrong about that enrollment schedule, but it hurts your point, not helps it.
If you make the exact same argument, and I mean word for word identical, yes, it tends to indicate that you are the same person. Especially if it is still completely irrelevant to the point you are trying to counter.
Data analysis takes a week or two, not a month or two. And the press release still states it is talking about all patients who had received 3 injections to date, not all patients who had been analyzed to date (and in fact discusses one patient who hadn't been analyzed). Therefore, your statement doesn't affect the timeline.
And if, as you claim you aren't Pyrr, making the exact same argument that doesn't make any sense doesn't help anything is kind of pointless. It doesn't matter how many additional patients were enrolled that doesn't affect anything.
And calling something I said as a hypothetical a "lie" is simply wrong. I didn't say it was true, I said it was as likely an explanation as yours.
The timeline proves that at least 4-5 method B patients were enrolled before the change in criteria. It strongly suggests that that both groups were enrolled together. Your entire counter argument appears to be based on the order of the alphabet.
Unlike you, all of us are stating opinions and theories, you are the only one who seems convinced that everything you say on an internet message board is meant to be absolute fact. Which is strange, because your arguments have less basis in fact than most.
Two thirds of the deaths under both methods were within the first six months. That argues, strongly, against the Method A 3 month, Method B six month theory, which has no factual basis in anything published, anywhere.
And it's that simple. If your theory is correct, despite complete the lack of evidence, then you are accusing NWBO of deliberate fraud.
If it is not, which the evidence supports (timing of your hypothetical changeover, correlation with early reports on the progress of the trial, various other posts on iHub and here), then B is clearly doing something, because it is superior to A, which may or may not be helping itself.
(Oh, and certain cancers, such as Throat, are still referred to as locally advanced, but staged as IV when the cancer has spread to different tissues in the same area.)
Wow, you just go deeper and deeper. Point to exactly where MDA says that about this trial.
And I didn't say I thought it was likely. I do think it is just about as likely as your theory, however.
Stage 4 does include locally advanced, and the criteria was stage 4, so that's a straight up lie on your part.
6 of A patients died within 6 months. So did 2 of 3 B patients. In case you hadn't noticed, that's exactly the same ratio. Unlike you, I argue facts, not made up guesses.
You're assuming that the limit on the number of injections equates to progressing disease. You have no more evidence for that than you are claiming we do.
I can think of several other reasons off the top of my head why injections might be stopped at that point. To go with the most positive one to counter yours (as the most negative) maybe by 16 weeks they couldn't find any non-necrotic tissue to inject. I'm not saying it's likely, but it's just as supported as your argument.
What we do know is that every single one of these patients was late stage 4, having already undergone multiple treatments that failed. Given that information, the survival data we do have looks extremely positive.
We also know (contrary to your statements over on iHub) that at least some of the B patients were injected under the original criteria, and it's likely that the split between original and later criteria is even between the two, and yet B is apparently much more likely than A to produce long term survival.
Therefore, your speculations are generally less evidence based than ours, and you can go away now.
Finally, and what all of us longs are hoping for, is a short squeeze. Since there is no limit to the risk, there is a strong incentive for short sellers to buy shares to close out their position before the price goes up to sharply (this is often enforced by the brokerage: since the purchase is typically out of a margin account, the brokerage can issue a margin call if the price gets to high). If there is heavy short interest in a stock, this will tend to greatly accelerate the rate of increase, since demand from shorts can be significantly greater than the number of shares typically sold. In this case, something like 20% of the shares on the open market have been sold short, meaning that if a short squeeze happens, it could cause the stock to run up hugely.
Realistically: Shorts are people who sell shares they don't actually own. They do this (legally) by borrowing the shares from someone who does own them (typically in a margin account). They are betting that the share price will go down sufficiently that when they return the shares, they can buy them at a lower price to do so. The profit is on the difference between the price they buy them at and the price they have to pay to return them. (Note that "naked" short selling does occur, when they sell shares that don't actually exist, this is generally, but not always illegal).
There are benefits to this in the general market, as it improves liquidity and helps prevent runaway share prices if a stock is over-valued. However, it is extremely subject to manipulation. Among other things, short selling artificially creates a greater supply of shares since both the person borrowed from and the person who purchased from the short seller are holding the same shares. This increases supply and lowers demand as a result, causing lower prices.
In addition, since short sellers in theory have no limit to their risk (a long, someone holding the stock can only go to zero, a short can lose as much as the price can go up), there is a strong incentive not to get caught when a stock is running up. In this stock in particular, there is a fairly strong belief that shorts have been attempting to artificially drive the price down whenever good news is reported.
Unfortunately, we don't know how long the patients had already survived with the disease before they entered the trial.
They might have been on chemo for two months before the inoperable tumors progressed, or they might have been on it for several years.
It's almost impossible to produce reasonable median OS numbers in this case, because we don't know how long they'd already been in treatment, nor the state of the disease when they entered the trial. What we do know is that all of them had completed standard treatment, and had not seen significant improvement. Most of them probably had at most stable disease, and more likely progressive disease coming into the trial. For those enrolled early in the trial, their doctors had given them at least three months to live and I believe that late in the trial, that was changed to a minimum of six months, but in both cases those numbers are a best guess by their doctor, as can be seen by the fact that four individuals died in less than three months.
On the one hand, most of the patients enrolled were in reasonably good shape for their stage of disease and treatment (ECOGS 0-2 early in the trial, 0-1 late in the trial. On the other hand, they were extremely late in the disease. Without personalized case histories, it really is impossible to make a call here.
Two of them died within two months or so. One of them died in barely a month. Almost definitely that is the deceased individual who only recieved two injections, and the treatment never really took hold. I would say the same is likely true of the other who probably received 3 injections.
The third one is almost definitely the one remaining individual in the B group that didn't have stable disease by week eight. That patient is also apparently an adult onset Desmoplastic small-round-cell tumor (I think that's what Desmo means), which is exceedingly rare, and agressive (it's usually a juvenile cancer. I'm not saying that's the reason DCVax didn't work, but of the cancers on the list, it's definitely the most unusual that I'm aware of.
Another useful tidbit for synchronization: May 14 2014 press release: 19 patients to date who have received 3 injections. Realizing that there are two patients who never received three injections, the timeline is still a little uncertain, but I think that puts May 14th somewhere between the 13 month patient and the 12 month patient.
When I say "got in trouble" I mean "were the subject of multiple attack articles and took a hit to the stock price". And that's not me thinking it, that's what actually happened.
And no, they were under no obligation not to reveal data, but that doesn't change what actually happened. See their press releases for around mid-may last year, and Adam Feurstein's articles posted in response.
And you are missing mine. No, they don't share data they aren't permitted to, and they aren't known for oversharing.
That being said, they very specifically did try to share Direct P1 data early, and got in trouble for it. Now that there's no question of that, they're in a position to share that information on a regular basis.
And I'm not saying I expect daily updates, but I think it's reasonable that, whenever they have a conference or press release for other purposes that we can expect to see current data on this trial.
They didn't do continual updates before because they got blasted for the one time they did. At this point the P1 is public information, so there is no question of releasing additional data being irregular.
One thing I haven't seen mentioned is that at this point we should get new information on the P1 patients on a fairly regular basis. Since this is not public information, hopefully NWBio will continue to update us as time goes on. The results are fairly impressive already, but if the patients (especially the method B patients) continue to do well, and the survival chart continues to stretch out, that will be a continuous supply of useful information.