Yes, but official documents are issued in German. And legal translation isn't something you can just plug into Google translate (as evidenced by the fact that AF's headline had "Uberseitzung" in it, which is not a word without the umlaut), and get results. A week or so of going back and forth to make sure the exact meaning comes through is not unusual.
From the press release 11 Aug 2014:
"Taking into account the time required for these approvals and implementation steps, and the 36-patient increase in the trial, as well as the gradual ramp-up of the trial in Europe, the Company currently anticipates that enrollment will be completed in approximately Q3 of next year, and the primary endpoint of the trial will be reached about 3-5 months after full enrollment or by around year-end next year."
DCVax-Direct Phase 1 Primary Endpoint (Safety) should be reached roughly Q1 next year, although that one I won't swear to. Phase II results, the Clinicaltrials information says June of next year, although a few months delay on that wouldn't surprise me.
By which time, the PI direct trial will be complete. The PII trial of direct will be complete unless something goes very wrong. The PIII should be complete barring significant additional complications.
If the company isn't in a position to raise 17.5m without blinking at that point, we'll all already have lost, so it won't be an issue.
The first treatment was in Q3 of 2013, per the press release of May 27th. Therefore by the time of the June press release, one or more patients had completed the trial. However, the early patients were treated slowly, with 2-3 weeks between patients (same press release), a restriction that wasn't loosened until March. Therefore, while several patients had completed the trial by June, it wasn't until then that a significant number of patients had received the 4th injection, which is when they chose to comment. They never said in that press release that no one was further along than 4 injections, they just discussed the state of patients after 4 injections.
I I am one of a dozen people who has bought 4 books at a particular store in the last month, there is nothing to say I haven't bought 5, or 6, or 50, just that only a dozen have bought 4 or more. You are reading something into the press release that isn't there.
To quote from the May 27th Press release,
" To date, 19 patients have completed at least half of the 6 treatments with DCVax-Direct, which are spread over 8 months. None have yet completed all 6 treatments."
"As is often the case with first-in-man studies, the Company’s DCVax-Direct trial was required, as a regulatory matter, to proceed slowly until safety considerations could be assessed. The Company was required to treat just one patient with at least 2 of the 6 treatments in the overall regimen, then wait 2-3 weeks before treating the next single patient in the same way, and so on, treating just one patient at a time."
"The DCVax-Direct trial began treating its first patients in Q3 of last year."
If they started treating the last day of Q3 last year, 32 weeks is may of this year.
This means that some patients had have completed the trial by the time of the press release you are referencing. You seem to think that a patient who has had 4 injections can't have had 5 or 6, and that just isn't true. They were reporting on the state after 4 injections because that is the one they had significant data on, not because that was as far as anyone had gotten.
No. There were 9 patients who had received the 4th injection BY June 2014, not in June 2014. That 4th injection could have happened 4 months earlier for one or more of them.
I'm not saying this is true or not, we'll see on the 5th, but your poor understanding of the English language doesn't inherently make it false.
That would be last Thursday. Or the week of July 28th if you want a more extreme example. Small biotechs are volatile, and not tied all that strongly to the larger market.
Dunno, why is it up 9.5% in the last month? It's almost like you're cherry picking your start point?
Bumping your own post is bad form. It shows that you're the only one who thinks you actually have something relevant to say.
Considering he is simply regurgitating AFs arguments, and considering that there are at least two false statements of fact in his article (that NWBO is hiding data when the DMC has confirmed they aren't, and the Buzdar is receiving money from NWBO), I would say no.
Proving libel is actually extremely difficult. First, AF must make statements of fact instead of opinion, the standard for what qualifies as opinion is fairly broad, especially for columnists. In addition the statements must be made with "actual malice, meaning they must be either "knowingly false statements" or made with "reckless disregard for the truth". Given that AF can claim a misunderstanding of the process in all cases, that I am aware of, legal action is unlikely.
Generally I am happy about this difficulty, since it is critical in maintaining the first amendment right to free speech. I'll admit there are times when it is annoying.
I don't think that's quite right. It's not, necessarily that the patients with the lowered white blood cell count have a shorter PFS/OS, it's just that their immune system is in such bad shape that DCVax, has nothing to work with. You can't activate a patient's immune system if they don't have one.
By separating out those patients from the remainder, NWBO has positioned themselves to show that the treatment can work on that remainder. The increased powering also means that even if the total PFS is shorter because of this group, they can still meet their goal because of the expected results on the remainder.
In the long run, and assuming DCVax works, this points to eliminating radiation treatment in favor of DCVax, and this group goes away as an issue.
The rapid progressors are a separate group, and they have been excluded from the study since it restarted, but those are the patients from the "information arm" that were reported on today and are showing such promising result.
Median doesn't move once you pass the halfway point. But it does mean that the 28th patient made it to 18 months when the odds were they only should have made it to 10, and it could mean as many as 27 patients are still alive and doing fine. We'll see what's what as more data becomes available.
Arms of a trial don't have independent null hypothesis. And it's fairly simple. The null hypothesis: DCVax-L does not extend PFS in patients with newly diagnosed GBM. The alternate hypotheses: DCVax-L does extend PFS in patients with newly diagnosed GBM, or DCVax-L does extend life in patients with newly diagnosed GBM who do not have hugely depressed white cell counts.
And it's interesting that you're willing to call the trial a failure when no one knows that until the data is at least partially unblinded. It's almost like you're hoping for a specific outcome.
No, the trial will be complete at 248, just like to previously would have been complete at 110, yet they still had interim analyses planned before the 110. I'm not expecting one at 88, I'm expecting it at 60% and 80% like the original trial methodology recommends.
I think it matters to the patients that made it to 18 months that they didn't die in 10, without nasty side effects, and I think it matters to those that are still alive that they haven't died when they were likely to.
Oh, and there's no reason why -L shouldn't apply to all surgically resectable cancers just as much as direct, once again, the critical step for the company's long term health is getting an FDA approval.
We already have the sort of data on -L that we'll get from the -Direct study (not quite as extensive, admittedly). What's critical is proving to the FDAs satisfaction that the treatment works, and that depends on a completed PIII study.