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I think section 6.5 of the DMC guidance provides a means and broad framework for NWBO to work with the FDA, DMC and Germans to develop specific safeguards making it possible for the German exemption program to review the phase 3 interim data.
P's encouragement for others to prey upon "lazy and emotionally weak" people is the thing. I think the majority are neither lazy nor emotionally weak. Instead, I believe they are well meaning, willing to help a good cause, naive in that they think the media is generally even handed and hopeful that their hard earned money may earn a return. Basically P and AF are (indirectly) arguing investors need a license before they get into this racket. So they feel justified in taking other people's money they 'accidentally' dropped on the street. I akin it more to pick-pocketing. I do understand the one thing that might happen without shorts is irrational exuberance, but to allow fraud, market manipulation and other deceptive tactics to prevent this is ludicrous. They created a Venus Flytrap with shows like Mad Money luring in the "sucker born every minute." It is sad.
Just thinking about this from a double-blind randomized trial framework, examination by certain entities does not remove the blind, nor does it endanger the trial as long as the 3rd party examination is carefully planned and executed.
It also reminded me that Linda Powers recently stated it will take about a year to get to market from the point the trial is unblinded (if memory serves).
So access and reimbursement in Germany will help save many lives while the EMA and FDA are sorting through matters -- during said one year window. The revenue from Germany will also help finance the NDA effort -- as you already know.
Very smart.
(Nice catch John)
In case anyone was worried about the average PFS in the last link I posted, remember that that study involved intranodal injections, which studies have demonstrated are not as effective. However, even with less effective administration, the OS was 28 months and the response rate was 80%.
The reason I linked the last article was because it focused on immune response after radio chemotherapy, which was the topic of interest in the post.
Alexius, thanks for the analysis.
Welcome to the board! How do you think the German exemption and reimbursement decisions will play out with the EMA?
RRRichmond, more to your point.
Below is a link to an article that answers your questions affirmatively -- namely, yes chemoradiotherapy GBM patients are immunosuppressed, and yes, Multiple DCVaccination over time helps restore the immune systems in many of these patients.
I would appreciate a more in depth discussion of the impact of existing SOC, over time, and how it affects the charged DCVax-L from some contributor more knowlegible of the biologic interaction of the two. Do you think that this might explain the need for multiple injections? RRRichmond
I'll try to respond to this in the next 8 hours or so. I have other obligations at this time, but the short answer is, I personally do not believe the SOC drug interferes too much with critical parts of the immune system early on. I believe techniques like hyperthermia will gradually replace chemotherapy, because it also weakens and kills cancer cells allowing the dendritic cells and the immune forces it potentiates to better recognize and eliminate the tumors. It is far more complicated than what I am explaining in my current distracting environment. Very short answer....I expect the results to be close to or even better than DCvax-L's earlier trials.
Moreover, waiting in the wings is a remarkable understudy.....Direct will not be an understudy for long Sir Richmond.
Well here is a late evening thought.
At one point I ran some ballpark calculations to see how rich Linda might become if NWBO and her other companies fired on all 8 cylinders. I think she might become the first public trillionaire.
Imagine how difficult it would be for someone fighting a lawsuit filed by her. Her resources would be unprecedented. I'm just saying.
Yes, Jim posted it once before, see post #5871.
It really makes me scratch my head. It seems like he is actually taunting the SEC. I'm not sophisticated enough to know if some statements demonstrate legal admissions. I do not know the context of the interview. However, it makes me upset.
When I first saw it, I tried to rationalize it like maybe Cramer was playing a cameo in some movie akin to the wolf of wall street, but I dunno.
It definitely is inexpensive right now.
The alternative (aka: New) uptick rule is in effect tomorrow.
I guess it depends on State Law….interesting. His "disappearing" accusation appears completely unsubstantiated. Combined, the fuzzy retraction may not be enough. Meanwhile the instit. accumulation and retail erosion continues. IMO.
AF thinks he might get a whiff of outcome if he presses hard enough -- IMHO. His attacks serve multiple purposes.
I figured Pris would get to you.
Anyway, we will just have to agree to disagree.
Be Well.
Pyrr, I'll try one more time, here's your latest quote:
He's a reprehensible human being but it won't stop me from taking advantage of the situation. You all should too. This means more available, quality, undervalued shares for us. Again, and I mean this: I hope he keeps it up. We all earn more because of it, and the only ones hurt by it are the lazy and emotionally weak. Why feel pity for them? AF hasn't hurt you, he's helped you. -- Pyrr
“Then we are stupid and we'll die.” --Pris
LTT Said:
So much negative sentiment at this point,
I think the stock drifts back down to about $5.00
Probably bounces around with "news", but never launches
again until we have real top line data, assuming that data
is good. Holding most of my shares ($3.50 basis), maybe
buying some more in the $5.00s.
Too bad yesterday's run was not for real. LTT
I agree with most of Beach's post; however the last part is fuzzy, and it does not quite align with the original premise. Still, it's a thoughtful post.
Your last name doesn't happen to be Branch, does it? I only ask this because I just offered one (Olive Branch) to longtermthinker -- not knowing the possible terrible repercussions….(for you that is)
Welcome!
Another Oppenheimer Day, another head and shoulders. (I get it guys….very funny.…not.)
No, no, no, no.
See, I had one more no so I win.
It wasn't just getting the translation, it was then resubmitting and obtaining approval from Germany to publish the translation.
And by the way, even though AF nebulously retracted his document delay accusation by 11:03am EST,he did not retract his accusation regarding their motive for waiting -- which he states is to hide the efficacy decision -- even going so far as to accuse NWBO of "disappearing" the analysis.
Lucy….I thinnn AF's gotta lotta splaininn to do!
OK.
addressing your concern:
Swamprabbit said:
….attacking cancer with antibodies as in dendritic vaccines isn't going to be a cure. Im starting to think its going to take genetically manipulated t cells or natural killer cells. its going to take something with some more punch. -- Swamprabbit
At 11:03 a.m., Adam stated, without providing one shred of evidence, that NWBO "disappeared" the DMC efficacy analysis.
Why has Northwest "disappeared" the expected interim efficacy analysis? -- Adam Feuerstein
Let me at least offer an olive branch. After we get the phase III results, I do hope NWBO starts having conference calls. I think this might eliminate a high percentage of these ridiculous attacks, or at least contain them to a quick question and answer forum where AF can have his bubbles deflated.
He is not joking. Maybe he thinks it is funny, but he is not joking. His response after that post convinced me of that. I hope he changes his mind.
Dok:
This is what Pyyrho said, I am leaving out some language in-between only to focus on the passages that concerned me.
I've changed my position on Adam F. I LIKE HIM. Look.. every time he spouts his drivel it works. Weak hands give up their shares…. If they were a fledgling operation with a single ph I trial and no money OK, it matters. But he is only helping us in this situ. So I've changed my stance. I hope he keeps it up. I really do. -- Pyrrho
Feuerstein retracted: In the same manner he backed down on saying NWBO would "blow up,"
Feuerstein used this passage at 11:03 a.m. March 12, 2014 to retract his previous statement.
Anyway, Northwest Bio says my story yesterday is all wrong because I just didn't understand that Germans speak German and Germany is really far away from America, separated by this big body of water known as the Atlantic Ocean.
I'm really glad Northwest Bio cleared up the confusion. -- Adam Feuerstein
I'm not going to go back and forth about this. If you can't see that disinformation distributed to well meaning people from a powerful source is completely dysfunctional and morally repugnant, then there is nothing else I can do to prove your argument incorrect.
With all due respect, your thinking is distorted.
You should watch some of those old black and white films where a team goes into the jungle to get rich by finding buried treasure and then start knocking each other off. It's amazing what greed will do to one's compass.
I agree with that caveat, and in fact, that is why I wrote the question the way I did. It's healthy to occasionally reflect upon the difference between traders and investors.
Think Oppenheimer will be buying the rest of this week? Oh yeah, sure you betchya.
The Jedi Returns. NWBO refutes AF.
http://finance.yahoo.com/news/nw-bio-refutes-false-claims-135900098.html
Here is my take. Linda Powers foreshadowed something when she said chemotherapy eventually kills the immune system. Note to self: Dendritic cells, T-Cells, Antibodies, etc are important constituents in our immune system. At first, however, chemotherapy can be synergistic with dendritic therapy.
Hyperthermia is not new to the world, and Pub Med has many studies confirming the need to further investigate this treatment. At a minimum, it definitely has demonstrated the ability to reduce tumor growth in some cancers.
It is my recollection, which isn't perfect, that Mistletoe cuts off blood supply to tumors. Very recently, as in last night (thanks to John's post), OXGN just had a successful phase 2 cancer trial with a synthetic drug that, wait for it, cuts off blood supply.
Germany as a country has a very robust and well regarded holistic medical approach.
I do not share the same concerns as Dok regarding Dr. Gorter's competitive results, because while he is using the same or similar platform as DCVAX-L on an experimental basis, he started after NWBO and he has no patents. He also seems supportive of NWBO on his website and in his references to trials in these areas. I'd be surprised if they don't collaborate at some level.
If I were dying of GBM before late June of last year, I would have flown to see Gorter. I bet you would have too.
I think this is the last opportunity for shorts to cover. IMHO
I did not find any link between Gorter and Israel.
My assessment is that he is an alternative medicine practitioner. When one works in disciplines slightly outside the mainstream doctrine, the mainstream guardians feel threatened. Thus they go on the offensive and try to lower the practitioner's credibility. I don't question the statistics Gorter gave. I think Germany would have questioned them some time ago if they were inaccurate. IMHO.
To my knowledge there is another interim look at 88 events, and a final look at 112 events. These looks may be moot if the DMC finds statistical efficacy for the current (66 event) review.
At the 88th event, they can review the statistical powering to see if they need to increase the size of the group -- IMHO that modification possibility is relatively unlikely. However, if it occurred, I'm not certain which group they would adjust -- the pseudo-progression or the primary-endpoint group.
But I repeat myself.
(Note reference to Oppenheimer in the connecting post)
The 8 year old compassionate use program in Israel does use DCVAX-L.
Yes, I'd go with E as well. E encompasses C, because C is inherently part of the due diligence required in E.
Glad to see you alive and kicking Austin. You might want to let Hodge know how a stellar family can pass a day or two on the outskirts of Houston. Get some rest.
Maybe this is still too soon. After 85 years. I'll say it anyways. It warms my heart that Israel and Germany are on the same page regarding their attempts to secure an effective treatment for cancer and comeuppance to death.