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Germany took out the pseudo-progression group from their proposed clinical trials.
Survey says 33k per year for three years for DCVAX-l.
Taking Into account Chigrai's, long's, Linda P's and other's guesses, then adding the fact that Germany's price will be more than many other countries (based on GDP, etc), next accounting for the fact that direct will be more expensive once it finally hits the market, I think NWBO will not go below 90k total in Germany, and I think Germany would be hard pressed to accept more than 100 k total for DCVAX-L.
Note: Using U.S. Dollars.
Welcome to the board! In her May 15, 2012 interview, Linda Powers was thinking 37K per year for three years (see below) (This would vary from country to country). I agree with you that penetration and saturation is critical. There was some manufacturing report quite a ways back where Cognate came up with a more cost effective manufacturing process. More importantly, here is what Linda Powers had to say on pricing, costs and the like in a May 15, 2012 interview.
Well, with these therapies, the healthcare system would not be paying for a hundred percent of patients to take a drug when only twenty-five percent of them get any effect of it [Because DCVAX-L has over an 80% response rate]. Secondly, the healthcare system would be getting a lot of bang for their buck with years of extended survival instead of two months of extended survival.
We plan to charge approximately in the range of thirty-seven thousand dollars a year per year of a three year treatment regimen, so about a hundred and ten thousand dollars for all three years combined, and with that we can still produce very nice EBITA (Earnings Before Interest, Taxes and Amortization) margins for our investors. As you know, that’s way below the pricing matrix. I mean Avastin is typically sixty to eighty thousand a year. Even all standbys like Temodar are fifty, sixty thousand a year.
JE: So you see the healthcare companies falling behind this once you have successful clinical trials and the product has come to market?
LP: We really do because of huge cost effectiveness and because of one more thing I haven’t mentioned to you, which is simplicity, absolute simplicity. The finished product is loaded in a standard syringe that every clinic on the planet has and it’s administered intradermal, under the skin, as a shot in the arm, like a flu shot or an insulin shot. That’s it. No three and four hour infusion of toxic chemo or even a three or four hour infusion of immune therapy. It’s a shot in the arm under the skin, that can be administered anywhere. Not just in these centers of excellence – which are great – but is not where ninety plus percent of the cancer patients get their treatment. They get their treatment in regular doctors’ offices and community hospitals, and so we’re positioning this to become a new standard of care and it has, we believe, the profile to make that possible. It has the clinical effectiveness. It has the cost effectiveness and it has the simplicity.
I go back to the importance of processing dcvax-l through the system first. I'm getting bad reception on my phone, but in a nutshell, there is an order to things. Direct's turn is coming. The European Union also has the 4b rule. 4b is critical to post phase 3 success because it will take 1 year to get ema and fda approval. That year patients will be saved by 4b. The price must be established in Germany, and it will be used as a keystone for other national pricing. It's too much to type on this little phone, but there are reasons to place the direct party on ice until dcvax-l gets a price point. The DMc decision is coming. I believe the pseudo progression group is the reason it's taking longer. It's a nonprimary endpoint, it's the equivant of a separate but equal trial, with separate analysis and ultimately complimentary. There is much more detail to what I am saying, but I think the agencies and nwbo are all trying to make this happen soon and without error. I think this is a very exciting time in the advancement of science, international medical cooperation, and we will look back at this with great admiration toward patients, governments, nwbo, scientists, doctors, caregivers and even investors. Nwbo listed some of the firsts they've accomplished thus far....that list will grow. Imho
Exactly. Great work staccani and everyone else.
Note: Others may want to read posts 6331 through 6335, and also post 6122.
Plus, as mentioned earlier,
I think section 6.5 of the DMC guidance provides a means and broad framework for NWBO to work with the FDA and the PEI to develop specific safeguards making it possible for the German exemption program to review the phase 3 interim data.
Staccani....put this together with the last couple posts, and the press release detailing that the PEI had all clinical data to date, and it pretty much ties all this up in a neat little package.
John, just a further thought on your older post.
Assuming Germany had the phase three interim data, a little extra logic is in order.
1. The PEI would not have made the decision to grant reimbursement and hospital exemption if the data was futile. This is simply obvious.
2. The PEI would not have made the decision to grant reimbursement and a hospital exemption if they believed the trial would continue.
This is not obvious at first, but it logically follows because Germany knows that its recent decision makes enrollment in Germany for the phase 3 trial impossible. The PEI would not interfere with their responsibility to contribute enrollment to the phase 3 trial unless they knew it was going to be halted for efficacy.
3. Therefore, The PEI fully expects the trial to be halted for efficacy.
Rosalind Franklin -- King's College.
That's all I need to know, but thanks for the education nonetheless.
There is a discussion about this article about a page and a half back, but I think it did not receive enough attention. Consequently, thank you for keeping this front and center. As RRR said, we have another catalyst! This is good for patients and everyone else -- except shorts.
You are tireless BB.
Another great article I missed. Thanks.
I was chuckling as well. Have a good weekend.
Long:
It is an open question for me whether the PEI got to see the Phase III data - I think it would make best sense that they did so as to make the best possible decision, but that is just my judgment. -- LONGUSA
6.5. Sponsor Access to Interim Data for Planning Purposes
Often, sponsors wish to have access to unblinded interim data for the purpose of planning product development, e.g., designing/initiating further trials or making decisions regarding production facilities. This interest is understandable, but such access is problematic for reasons already discussed. In general, sponsors are advised to avoid seeking information about unblinded interim data because of the significant possibility that they may wind up impairing trial management or even making the trial results uninterpretable by doing so. Further, plans or decisions based on statistically imprecise interim data may often be suboptimal. Where the sponsor nonetheless has a compelling need to review such information, certain approaches may lessen, although they do not eliminate, risks to the trial:
Discussion of such an action with FDA in advance. This is particularly advisable when the sponsor intends to use the study in support of a licensing or marketing application.
Development of appropriate stopping rules and apportionment of type I error (a) before performing any unblinded interim analysis. This is important because any viewing of study arm-specific effectiveness data by the DMC and/or sponsor in a study of a serious illness raises the possibility that an unanticipated extreme finding of effectiveness might create an ethical imperative to stop the trial, and it would not be possible to quantitate the level of evidence provided by the data if the monitoring plan had not been established prior to data review.
Determination of the minimum amount of information needed. For example, to assist in defining eligibility criteria for a subsequent trial, the sponsor may wish to know only whether estimates of treatment effect in a subgroup are less or greater than in the overall data set.
Formulation of written questions, preferably with yes/no rather than numerical answers, that will elicit only that minimal required information and nothing more.
Receiving only written information regarding the requested data (thereby documenting what was received and avoiding additional unnecessary communications) and abstaining from participation in closed DMC meetings or discussions of data with unblinded DMC members (except as otherwise requested by the DMC).
Identification of those sponsor employees with a critical "need-to-know" and restriction of such information to those individuals only.
Ensuring that individuals with access to the information avoid any subsequent role in the management of the trial and minimize interactions with others in that role.
Ensuring that individuals who have access to such information make every effort to avoid taking actions that will assist others in inferring what the information is.
Ensuring that reports of study findings describe any access to interim data by individuals involved with study management, and steps taken to prevent such access from potentially biasing the study results.
It certainly provided impetus for me to look up how to spell....
Entendre:)
Great insight Etienne!
BBKing and RRR, nice work regarding the info on the early access program in Great Britain. Wow, what an amazing international effort this is turning out to be. I think you nailed what implications this may mean for NWBO.
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