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Long.
Carroll is a friend of the shorts who are being squeezed right now. Notice he does not mention the compassionate use programs in Israel and great Britain. Notice he does not mention the Cologne medical center progress. Over 200 patients getting over 1000 treatments with over an 80% clinical response rate, and he'd say something as pathetic as this?
The sale of an unproven cancer vaccine directly to desperate and dying patients, meanwhile, isn't likely to win the company many new friends
Yes…Where is Austin?
Note: I added a bit more on the intraday dip today.
Red.
I think you are right. The barrier to entry in Europe is much higher for those trying to follow in the footsteps of NWBO.
On a pricing note, I think the following passage from NWBO's PR is important.
NW Bio also announced today that the German reimbursement authority (Institut Fur Das Entgeltsystem Im Krankenhaus, or InEK) has determined that DCVax-L treatments for glioma brain cancers are eligible to obtain reimbursement from the Sickness Funds (health insurers) of the German healthcare system. Applications for such reimbursement eligibility may only be submitted to InEK by German hospitals, not by a company. Six major hospital centers across Germany applied for such reimbursement eligibility for DCVax-L for glioma brain cancers. The amount and terms for such reimbursement will now be negotiated by NW Bio, the hospitals and the Sickness Funds over the coming months, and will be applied to patients case by case. In the meantime, patients may self-pay for DCVax-L.
High pitched squeaky clicks,,,,,dancing on water backwards followed by a quadruple-twist-cork with minimal splash.
Also, thanks again for writing that e-mail to NWBO.
Dag nab it…I forgot Diamond Jim. What stellar contributions you make to this board -- Diamonds in the rough. I guess I need to look at the poster list.
I am certain this day brings deeper meaning and satisfaction to you. Cheers.
If I were a short, which I never am….
I would concern myself with the national and international news that will flow from these PRs.
In other words, we've had a Press Release, now we are due for a mainstream Press Reaction. Analyst upgrades are probably being considered as we post. These things are important for the company because more warrants and options are exercised as the price increases thus reducing the need for financing prior to ASCO in May. After ASCO, any fund raising will have a minimal effect on the price per share. This is good for investors and patients because it means that production capacity and trial completion are no longer mired by any funding issues whatsoever.
The crescendo stands at mezzo-forte thus far. Just wait until Ode to Joy and the 1812 Overture.
and Long too….I thought I put your name in my last post (oops). Thanks for every word of wisdom, experience, moderation and insight you graciously share with this board.
John,
Red, Ou, Sitiain, GPB (If you are out there), Bio, Etienne, Dok, Hodge, etc…. Well done!
(I'm currently parsing through the PRs.)
We are good! It's good to be long.
Shout out to Larry Smith….that guy knows his stuff.
I'll be back in a bit.
Green light was right!
I have an unorthodox morning today, so I'll join the posting party later. Save some cake.
Wow! That last quote said it all.
Yes it would. The pseudoprogression separate blinding, randomization, "desired" # of trigger events and separate but equally important D.M.C. analysis is, in my mind almost certainly the reason for what we regard as a delay.
I personally believe people like AF, with his stealth institutional brain trust of good old boys, knows this is the case as well.
I've come to the conclusion that AF's nwbo articles and the like, combined with actions like oppenheimer's head and shoulders maneuver back in November serve more than one purpose. I think the secondary motivation by THE MAN is to keep common people away from smart individual investing.
I think your interpretation is a fair reading.
RE: The alternative group….you almost need to look at the pseudo-progression trial as another trial that does not direct the primary trial, but instead must not be forgotten. These aren't sneak peaks against the rules for sequential analysis; instead one trial has possibly reached its primary endpoint, but the second trial must not be destroyed by prematurely unblinding the first. The "second trial," so to speak, must be handled just as carefully as the first, but investors have no idea that is the case. Ultimately, they also must be evaluated as one unit.
Maybe that makes more sense.
Correction to my last post:
The sentence in bold was pasted after the wrong paragraph in the last post.
This is the correct version,
IMHO, there was a degree of timing placed into the trial.
The timing is a bit off, so the world has to wait.
If the Pseudo-progression enrollment didn't start until 2011 or so, then it may be the 72 spaces they added to the trial are for the them.
Do some very simple math.
Ultimately 240 in the main body.
Ultimately 112 events required for final analysis
66 required for 1st interim analysis.
72 in the alternative group (pseudo-progression)
Ultimately 33 events "desired" for final analysis.
19 "desired" for 1st interim analysis.
If you met the primary endpoint in the main body, the pseudo-progression group is not an afterthought. They are just as important, and you would want to analyze the results before you unblind the trial. You would not want to neglect this very important group, and even though they are analyzed separately, ultimately you would want to also determine how both groups did as a whole. This would explain why they are telling us efficacy data analysis is pending.
If you were simply going to continue the main body of the trial, you could simply do that and analyze the pseudo-progression group at the second interim analysis for the primary group. You would not wait for the pseudo-progression minimum events at the 1st interim analysis in this situation.
Finally, there would be simply no reason to halt the trial for futility at the 1st interim unless the results on the primary group were showing a statistical detriment (which would be a safety issue -- and there is no safety issue) to the patients. Thus the safety continuation is more meaningful at the 1st interim than perhaps any other time when you have a very safe treatment.
IMHO, there was a degree of timing placed into the trial.
The timing is a bit off, so the world has to wait.
If the Pseudo-progression enrollment didn't start until 2011 or so, then it may be the 72 spaces they added to the trial are for the them.
Do some very simple math.
Ultimately 240 in the main body.
Ultimately 112 events required for final analysis
66 required for 1st interim analysis.
72 in the alternative group (pseudo-progression)
Ultimately 33 events "desired" for final analysis.
19 "desired" for 1st interim analysis.
If you met the primary endpoint in the main body, the pseudo-progression group is not an afterthought. They are just as important, and you would want to analyze the results before you unblind the trial. You would not want to neglect this very important group, and even though they are analyzed separately, ultimately you would want to also determine how both groups did as a whole.
If you were simply going to continue the main body of the trial, you could simply do that and analyze the pseudo-progression group at the second interim analysis for the primary group. You would not wait for the pseudo-progression minimum events at the 1st interim analysis in this situation.
This would explain why they are telling us efficacy data analysis is pending.
Finally, there would be simply no reason to halt the trial for futility at the 1st interim unless the results on the primary group were showing a statistical detriment (which would be a safety issue) to the patients. Thus the safety continuation is more meaningful at the 1st interim than perhaps any other time when you have a very safe treatment.
By the way, I don't want to leave people hanging.
If this hypothesis turns out to be correct, I see it as
a positive development.
See you all in a while.
I have an idea.
According to clinical trials.gov, the pseudo-progression group is analyzed separately.
When you fully contemplate what that may mean, you will conclude that the p.s. group also needs some basic number of events to occur for statistical analysis. (This would not be a primary endpoint event trigger.)
I could ramble on until I am blue in the face with hypothetical numbers, but I think we may want to consider the fact that the pseudo-progression enrollment probably did not start until 2011 or sometime shortly thereafter.
Think hard about that. Really hard.
Ultimately, we may be waiting on a number of events in a separate group all together (or maybe they just recently reached that number). I do not think that number of events would be very large. Even though the p.s. group is not used for the primary endpoint, it would be really important to have enough powering in this separately analyzed subtype.
That may explain the delay and why efficacy is still under review.
Before you make such strong statements, you may want to make certain you know what group is responsible for conducting and issuing the interim review decision.
I'll let somebody else speak to New Link.
Nice Ou,
Thanks. This will be the third day in a row that I am adding.
Not quite.
IMHO, the data safety monitoring board still has the 1st interim analysis under review for efficacy. They can't take a look at any new data for probability until the 2nd interim analysis. Therefore, they are still reviewing efficacy with the data they have. This is the way sequential analysis works. You cannot peak at probability data inbetween the 1st and 2nd analysis.
Consequently, if you take the PR at face value, they are still considering efficacy with the present (66 events) data set.
"Review of the efficacy data is still pending"
Not just lip service.
Considering Marnix Bosch's position in this trial, I think his comment in the press release carries additional weight.
True. Unless volume skyrockets.
I agree, but I think it will take some further PR to move PPS significantly. IMHO
Dok said:
….and possibility of a PR on Direct progress in 2 weeks if they did not get accepted to ASCO.
Note that ASCO rejection would not necessarily mean the data is not good enough, just not mature enough at the time they submitted, which was some time ago on the relevant scale. Acceptance would be a plus, but denial might be even bigger because they said they would then be in a position to share progress.
Yes. That was required by Germany.
I agree, I think that's the correct general take, but I think it's also a green light to the clinics in Germany.
I think this is a green light to proceed with clinical enrollment in Germany so NWBO can get more data to ensure eventual passage with FDA and EMA. If we halted for efficacy right now, Germany would be switching over to full on compassionate use, and they'd probably lose enrollment capacity in the trial, which would mean we go with the enrollment we have. There is still a chance we will here something on efficacy soon regarding the group Germany is not including in their enrollment -- (pseudo-progression) IMHO.
Good question.
I go back to the fact that it takes more extensive deliberations to determine if they are going to stop for efficacy. This initial decision (continuance for safety) gives the DMC (and possibly CRO) breathing room to perhaps follow the path Ou and f3tt3f suggested, which is to wait for the 88th event. This allows more data for any eventual presentation to the FDA.
This may mean our next "glimpse" on anything DCVAX related will be a "shout from the rooftops" at ASCO in May on DCVAX-Direct.
Still, I expect some announcements on Germany (reimbursement?) and DCVAX Direct clinic expansion in the meantime.
Its kind of a continue….
"The DSMB’s review of the efficacy data is still pending."
Brilliant.
I agree that this is an important factor. I also agree with your analysis. I also think the chronology of this trial reduces the burden on the d.m.c and nwbo regarding p.f.s v. o.s. endpoints.
There seems 2b a guiding hand.
P.S. You brought to mind that gifted actor from England. When he used the word "Guinea Pig" to describe his situation..... I knew nwbo had more to contribute than a cancer breakthrough. I think this trial will b seen by future historians as step toward the end of placebo trials.
Maybe,
but I think if that were the case, they'd just announce a continue. No harm in that, and it avoids driving everybody nuts. I just don't think they'd wait for 22 more events without announcing a continuance in the meantime. This theory would also be outside the standard prearranged structure.
IMHO, I think there is a different reason.
Dunno. My thought is they are too smart not to have one.
Yes. That is the one I am referring to.
Once a stock has dropped 10% from its previous day’s close (even if just briefly dropping that far) the rule will then be in effect for the rest of the day and the next trading day.
Alternative uptick rule in effect all day tomorrow.
Your humor won't be lost or misconstrued….
I'll repeat myself, at the risk of being crude….
More extensive interactions might occur [between the steering committee and the DMC] when early termination is being considered….
It follows that if the company is going to share the DMC recommendation right when they get it, there must be a steering committee beforehand engaging with the DMC in more extensive interactions while any early halt is considered.
Otherwise it would cause complete chaos to announce a decision and then contact all the clinics, countries, etc.
Jim's correspondence with public relations helps us discern this process from a more sophisticated perspective. IMHO