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.
Yeah, I missed a paragraph in the PR. But they are calling for top-line results by the end of next year, so I'll stand by the rest of my statement.
You're right. I did miss a bit, you still don't explain why the timeline involves "rosy" EU numbers, and my estimate for completion is still accurate. I'll hold another year for a cure for cancer. And that assumes no early halt for efficacy, and no blockbuster success on -Direct.
Low white cell count and the 55 rapid progressers are two completely different issues. The low white cell count group is now a sub-group within the trial, and separating them out for analysis greatly increases the chance of the remainder of the trial succeeding.
The rapid progressors are individuals who were never included in the trial based on the criteria "Patients must not have progressive disease at completion of radiation therapy. Patients with suspected pseudoprogression will be enrolled and analyzed separately". These patients were treated under the expanded access program under clinical trial listing NCT02146066.
It's only bad news if you aren't in it for the long haul. By making this change, they just greatly increased their chances of a positive result.
And yes, this probably does explain the lack of efficacy data to date, that doesn't mean that we won't see any information until 248 events, since I'm certain interim analyses are still included in the new schedule. However, since they didn't announce any new enrollment timeline, your comment on "rosy projections for EU enrollment" is based on absolutely nothing. Based on their reported enrollment to date, I'm guessing we're looking at enrollment completion by first quarter next year, but it's just a guess. That last patient would hit 4 months increase in PFS just about 11 months later, or the tail end of next year, so that's about the worst case timeline.
In light of the other PR, I would say because they are still waiting for statistical significance. Remember, no matter how good the numbers look, the FDA doesn't approve until you can show that it wasn't just random chance. 55 patients with no control arm looks wonderful, but (purely as devil's advocate) it could be down to a new treatment procedure outside of the study relative to SOC.
Once it shows the same sort of improvement over the control arm where everyone is getting exactly the same treatment except for DCVax/Placebo, that's when we get movement.
First, the retroactive bit. This means that the -L P1 trial was as successful as it was, despite these low white blood cell count individuals, which indicates it was incredible among the remainder.
In the short term, however, this expansion means that it will be somewhat longer before we have an actual, final result. I would guess the enrollment completion is now extended out to (early) Q1 next year, and the event completion could be noticeably further out.
In the long term, obviously finding and isolating the LWBC group should greatly increase the chance of a successful trial for the remainder.
Now the more speculative bits. I would say that this indicates a promising possibility of a DCVax type treatment replacing radiation as the standard of care in the near future if it is as effective as we all hope, since it won't do this sort of immune system damage.
Also, I would suggest that this change (given the timing) explains the "missing" efficacy report, since NWBO would not want to receive an efficacy report that early under the new scheduling, which they knew about when the safety recommendation was released.