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One year, and it can start before phase 2a is complete.
There are some who believe the current phase I and II will be enough for FDA and EMA approval. This is because of the incredible results expected and the terrible position these patients find themselves in. I'm open minded on this optimistic projection, but I'll simply wait to see phase 1 results roll in before taking a solid position.
You answered my question correctly, as you already know. The trial was planned just this way. I cannot devise a better trial to avoid including SOC (chemo), get approval for all solid tumor cancers (operable and ultimately inoperable) and move it through a series of very fast trials so that it gets to the world in the shortest amount of time. Cheers to NWBO.
Be well.
Welcome to the board! I'm sorry you are leaving so soon.
Aha! Now you know why the running back makes the 20 yard pass.
Look at ClinicalTrials.gov. DCVAX-Direct. Do you see any standard of care immediately preceding or concurrent with treatment? Look at DCVAX-L on ClinicalTrials.gov and see how it looks when chemoradiation is added as part of the protocol.
Now you get it!
Ask yourself this question. Why are they foregoing Standard of Care? Why did the FDA allow them to forgo standard of care?
Why then am I suggesting Direct will charge more? I'll answer that one. Because they know it won't need to be combined with expensive chemotherapy.
NWBO won't release any planned protocol for the pivotal (i.e.. phase IIB/III) on Direct at least until we pass ASCO. It will be by (initial) direct tumor injection however, because in this technology, method of administration is as critical to efficacy as the treatment itself.
Pyrr, I only responded to part of your post last time. If you believe Direct only treats the injected tumor, and you believe Direct has no place in metastasized cancers, I humbly encourage you to read the on-and-off discussion about the Triozzi study this board had at the end of last year and the beginning of this year. Keyword: Triozzi Keyword: Patent
I think you'll be pleasantly corrected and happily surprised.
You also need to look at NWBO's past presentations regarding the maurine studies on direct, with special emphasis on long term immunity and Direct's effects on non injected tumors.
No, you were not necessarily right about the Germans not having access to the blinded data. There are firewalls set up in biotechnology companies so that the person speaking to the public usually does not have access to Section 6.5 details, FDA and PEI workings, and the like. Linda's comment is so carefully worded that it precisely fits the statements one would make on the blinded side of the firewall, and yet it still allows room for the alternative. This is to maintain the blind effect, enrollment potential and data integrity until the trial is officially unblinded.
IMHO, quick does not mean a couple years for each extension trial on Direct (perhaps on L which will become unnecessary IMHO -- and there will be no need for extension trials on Direct -- only post approval trials). The "discussion shifted," because as I have said before, their is an order to things. These 2 treatments are intimately related in NWBO's strategy.
Let me humbly present a homely analogy. Provenge is the blocking fullback. ICT-107 is the tailback.
DCVAX-L is the running back. Percy Harvin is DCVax Direct.
Provenge fakes getting the handoff and makes a critical block, the quarter-back pitches to the tail-back who does a reversal hand-off to the running-back who makes the 20 yard throw down field to Percy Harvin, Percy Harvin outruns everyone on the field. TD.
Let me suggest to you that Direct is already used on what you probably consider operable cancer. Go to clinicaltrials.gov and see how they broadly define "inoperable." Now ask yourself, is there a biotherapeutic difference in treatment response to DCVAX-Direct based upon whether the tumor is "inoperable" or not? Having answered "no", take it one step further. When both are on the market, Which one would you pick to save your life?
Also, if it's insurance you are concerned about with multiple cancer type treatment with DCVAX-L, let me suggest to you that all of Europe, Japan, Great Britain and many other countries already have the equivalent to " Germany's 4b hospital exemption" statute, and the United States is contemplating this in the very near future -- albeit having to work it through a different regulated insurance system.
Perhaps there is a happy medium. "Ethics" trumps "perfection" -- that's true -- but ethics must also weigh whether tens of thousands of people will have to wait for a second phase 3 trial versus waiting a little longer before unblinding this trial, and thus getting through the FDA and EMA based upon just one phase 3 trial.
They likely will not need to. First, there is off label use in the United States. Secondly, if you simply reject off-label use is an option before more DCVAX-L studies are completed on different cancer types, let me suggest that the Direct platform will beat any such post-approval label extension studies to the finish line. While safety is the primary endpoint in the phase I/II trial in Direct, Tumor regression and/or lack of progression is the secondary outcome measure. In any IIB/III pivotal trial for Direct, tumor regression would be the primary endpoint/outcome. This is the fastest route to approval there is in cancer trials. The events happen at lightening speed, and unlike the first phase of the Direct trial, there will be no first-in-human bottleneck protocol to slow it down -- and remember, direct is for all solid tumors.
I think it is important to point out that one cannot lump all members of NWBO on one side of the firewall or the other. In practice, from all the general rules, guidance and so forth i've read, some people within NWBO would likely be in the know regarding certain matters (i.e.., PEI and FDA conversations about data), and therefore screened off from the public (and other NWBO personnel), and others would be intentionally in the dark, so they can continue making public statements.
This is all done to preserve trial enrollment, the blinded study and data integrity. Thus, Linda Power's comment about what Germany based their decision upon is appropriately naive, while leaving room for other possibilities.
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.
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 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'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.