Pick a random trial phase biotech company, find me that information on them. AF doesn't have it. There's no reason to think that the patients were cherry picked, yet he has been accusing NWBO of doing so for months (years?) now. This is despite the fact that he was writing articles in favor of IMUC at the same time.
His entire argument is "IMUC didn't produce statistically useful data, therefore the somewhat similar NWBO can't possibly work.
The two approaches are similar, but not identical, and even the IMUC data is not catastrophic for them at this point.
Where are you getting that information? She has outright purchased, at market value, a huge number of shares. As has Toucan, which she controls.
PII was, I believe, 100% treatment, so all of the people transferred over to the PIII are treatment arm.
You are confusing the DCVax-L study with the DCVax-Direct study. -L started in 2007 as a PII, and was restarted in 2011 as a PIII. They have 33 treatment arm cases carried over from the initial enrollment, and have been enrolling for 2+ years since then. Given that they expect to complete enrollment around Q3 2014. If you assume constant enrollment you get about 8 patients a month, meaning 200 already enrolled. That's probably on the high side, since enrollment would have ramped up over time, but it's a starting point.
Because people were asking, and the two are commonly seen to be derivatives of the same technology, and because NWBO took an unwarranted 10% hit on IMUCs bad news.
And this trial is for newly diagnosed Glioblastoma. Therefore the sole treatments are the surgery that removes the tumor, and standard chemo treatments with specific drugs. All of this is listed in the trial at clinicaltrials.gov, and therefore you are wrong to say it is not available.
Yes, we could have more information on enrollment numbers. However, most of the information you are asking for remains hidden by the blinding of the trial, and some of it by HIPPA. And what do you mean "what is the nature of the control arm"? It's a placebo (most likely saline injection).
Not that I particularly care, but unless you have solid evidence to back that up, you might want to look into the libel laws.
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.
It's pretty much up to her whether it gets bought out, between her direct/trust holding and Toucan (and through them Cognate), she controls an awful lot of the company.
Agreed, there's no way this trigger, at this point, is not indicative of at least some improvement due to DCVax.
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.
Or, you know, they needed more cash in order push through the next bit of the trial before they're in a position to release results.
You missed this bit:
"The units are being sold at a public offering price of $4.80 per unit. Each unit consists of one share of common stock and a warrant to purchase 0.5 of a share of common stock at an exercise price of $6.00 per share. The shares of common stock and warrants are immediately separable and will be issued separately. The underwriters will purchase the units at a price of $4.488 per unit, representing a 6.5% discount from the public offering price"
That is in regards to the original offering, not the over-allotment. That's where the underwriters make their money for underwriting. So it's not an initial incentive, and the shares are still offered to the public at the $4.80 price. This is exactly the way these things normally work.
Oh, and we're only below "average volume" if you only average the past week. We're still way above the average volume for any longer time period.
Where did you get that information? It doesn't match the article, which lists an extra 3.525 million for the 734,374 shares, which works out to exactly $4.80 per share.
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.
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.