No, you're a liar. You get paid to do this. This IS your day job.
You're the liar. You deleted all your posts after the collapse. Except this one -- you missed one.
Reply to antiyaya_yes- ENJOY YOUR BEATINGby usicktroll2 •Feb 13, 2014 10:45 AM
antiyaya_yes antiyaya_yes • Feb 13, 2014 11:01 AM Flag0 users liked this posts users disliked this posts 0 Reply You little illiterate A -- hole. I am waiting for it to be oiled up to $500, okay! So, buy, buy and buy. Help me get that level quicker!
You might want to go over to the GALE board and get that one off there too. Sloppy sloppy!
Hey antiyaya, by the way, interesting to note that you were also a pumper of GALE before the bottom fell out.
From one-offs signing up for treatment with no real efficacy data available and no full approvals in any jurisdiction? I think I can count the takers on fingers and toes, and the profits will be negative.
Ask the shareholders of GALE if they think that the people who uncovered the stock promotion scam were doing something "bizarre". This is a publicly traded company subject to securities laws and regulations, operating in a space where lives are at stake. There's a standard of behavior and disclosure here. In my opinion, that standard is very far from being met.
Also note that there is STILL not a single German site officially recruiting patients in the trial. You can check for yourself on clinicaltrials dot gov.
By the way, in retrospect, I'll bet Linda Powers was wishing they had set the interim at 50% of events. The p-value for futility at 50% is right around p = 1, I believe (depends on futility method, of course). At 60%, it drops pretty substantially -- more like p = .4 or .5.
I believe the drug is inert and so at p = 1 it would be a coin flip. At p = .4 it is much more likely to fail (it's not a linear distribution and I'm not THAT good at the math offhand).
Another interesting thing to note is that, considering how long this trial has been going on, the number of enrollees needed to get 66 PFS events is not very high. It's possible there are 150 or less patients enrolled right now.... could even be less than 100. This is (again "likely") why you've heard nothing about enrollment counts, and you're not going to.
All IMHO, of course.
You paid pumpers need to work a little harder. It's 60% of events, and the trial achieves whatever power they're claiming by assuming an absurd improvement in PFS (some crazy like a doubling). The "perfunctory continue" was anything but perfunctory -- the word for it is "bizarre", as peeling off the safety from the efficacy and claiming the efficacy is "pending" is strange at best and indefensible from any normal perspective.
Feuerstein is asking the right questions. Note you still don't have any answers to them.
The stock price will continue to erode until the company releases credible information about the interim efficacy data. It is likely that this data is available and has been for some time.
The problem, most likely of course, is that the data are poor. If they weren't, we'd have heard a perfunctory continue by now. (It is extremely unlikely we'd see a stop for efficacy given how underpowered this trial likely is in reality.) So management is likely trying to figure out how to spin the data to justify continuing this trial, and may be in heated discussions with the DMC.
Note that everything I have said is conditioned by "likely". My speculation only. I *know* no more than anyone else does here about what's really going on.
Dagg: the German approval requires no demonstration of efficacy. It's basically a compassionate use approval, in part because the drug is personally customized (like Provenge).
They took two years to get this approval. It has nothing to do with the Phase III data.
At least that would fill the gap from $6.06 to $6.36, which would improve the technicals, until the trial failure is revealed, at which time technicals will become irrelevant.
Good news: NWBO stock is now trading at more reasonable levels than when it spiked over $10.
Bad news: At $7.80 per share, the price is still overvalued by roughly $7.80 per share.
Summer, I think his use of the word "significant" was inadvertent, not meant to be connected to "statistically significant". I think he's thinking if you have clinically significant outcome (3-4 months improvement) and a p-value in the .05 to .10 range, then the trial might count as "confirmatory" in combination with other stat sig (or almost stat sig) trials. Have seen this line of reasoning before work with the FDA.
NWBO is most likely trying to figure out a way to continue this trial, but they probably are in the predicament of having to do that OVER the recommendation of the DMC to stop the trial for futility.
They probably have the ability to continue the trial under the DMC Charter as long as there are no safety issues, but if this is true -- and I'm just speculating -- then they won't be able to say that the DMC recommended a continue based on the efficacy results. They'll only be able to say that the trial is continuing.
And with the level of scrutiny here -- especially from Adam F -- THAT is going to raise a LOT of red flags.
Again, just speculating. No way to know at this point.
Yeah, right. That's what we do in America. We silence journalists when they legitimately question the suspicious practices of a publicly-traded company. Pretty soon there will be plenty of stuff here to talk to regulators about, but Adam F will have nothing to do with it.
So the DMC comes back and says, "You've crossed the futility trigger on your primary endpoint. For PFS, the p-value is approximately 1, and there is no chance that continuing will result in a stat sig outcome for this trial. We recommend you stop the trial. The final decision, however, is with the sponsor as the safety data are fine."
"What? Are you serious? What about the survival data?"
"The p-value is a little lower, but nowhere near stat sig. Same conclusion on that."
"Nonsense. We've seen long-term survival in our poorly run, cherry-picked early trial. We should continue the trial so that we can observe more long-term survival benefit even though you've seen nothing so far, including in the patients who enrolled a long time ago."
"uhhhhh, like I said, the final decision is with the sponsor given the safety profile."
That's how long it was supposed to take to analyze the efficacy data...
Guess what? It's now been THIRTEEN (13) weeks. Which is 3 months.
The efficacy data has been analyzed. What's pending is how to spin it.
That, my friends, takes some time.
I looked it up. It means "awaiting decision or settlement"
So in this case, I guess we're "awaiting the decision" on when to take the hit for P = 1.
My guess is: after the big secondary offering.
But I'm just guessing.
The company was able to spend two years constantly interfacing with German regulators in the process of getting the Hospital Exemption approval, and suddenly they can't read German (or get someone at their German partner to read it)!!!
ROFTLMAO.... what a complete joke!