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No, it is not. There are 36 patients in the first phase. There are 24 in the next phase. According to all the literature I read on dendritic therapy and immunotherapy in the past, the results should become stronger. There is enough evidence right now, if one has studied immunotherapy, for any large pharma to sayā¦.Uh-oh. There is enough for any inoperable patient to place this trial in their top 2 choices. There is enough for NWBO to continue manufacturing expansion. There is enough for investors to know it is more than promising. If these were the only patients in the trial, then there would be enough for SS, but the trial would be too small to utilize. You need a "moderate" sized single arm trial measured against historical data to make a determination that the results are "dramatic enough" for approval in an otherwise untreated population group with an imminent serious/terminal prognosis. There is much more to say, but that is the minimum. My position is they can get there on phase 1 plus early (aka: incomplete) phase 2 data without a blinded trial. Many post approval one arm confirmatory studies would then be required. (I'd reiterate, the FDA's speed to approval may even surprise me.)
Excellent piece theel.
Perhaps by giving each treatment a different name, even though it is the same biologic, I can drive the point home to would be investors.
Many companies use their drugs for different purposes and therefore give them different brand names. DCVAX-Direct, like no other treatment before it, covers a number of applications. All of a sudden you realize how large this company really is -- if it continues to show progress across multiple cancers. The following is an imagined list (DCVAX-Direct already appears to work in some), but if Direct proves itself against the cancers below, it might look something like this.
1. Breathe Easy vaccine for Lung cancer.
2. Recover Vaccine for Colorectal cancer.
3. Fightback Vaccine for Breast cancer.
4. Sweetlife Vaccine for Pancreatic cancer.
5. Reanimate Vaccine for Prostate Cancer.
6. Liveagain Vaccine for Liver and intrahepatic bile duct cancer.
7. Overcome Vaccine for Ovarian cancer.
8. Speakwell vaccine for Esoughageal Cancer.
9. The list goes on and on.
While my names leave much to be desired, my point is, this really is a very large company with a gigantic pipeline.
Spot on!
By September 1, 2014:
1. 36 DCVAX-Direct patients will have 4 or more injections each.
2. DCVAX-L Phase III trial may be near full enrollment.
3. UCLA DCVAX-L and adjuvant trial may collect final data.
Over 1,500 people die of cancer each day.
How many people do you think are dying of cancer this year that could use this treatment?
Well done.
4 injections in 8 Weeks. 9 of 9.
I think your position is very sound. I'm clearly expecting more from the FDA than in the past, but I think they are ready and willing to go there. I am really advocating a position -- not an investment strategy.
"Dramatic Enough" Results. That is the key Pyrr. IMHO. With a continuing stellar safety record of course.
Linda stated in a recent conference call, I forget which one, that DCVAX-Direct will benefit greatly from the German regulatory advances made with DCVAX-L; as well as manufacturing and distribution.
These people go home to die. That's it. The longer the FDA takes, the more people die. That's it.
There is a huge difference when there is no medical treatment available. That is what these expedited programs were created for. I agree with the methods you project they will use, just not the timeline. The FDA will also use priority review. I think this gets approved based upon the initial phase 2, and the remaining applications are readily approved through label extension with single arm post approval studies to validate the findings.
Expediting Availability of New Drugs for Patients with Serious Conditions
^^^Press Link Above^^^^
Note, while the link site above addresses a specific form of cancer, the webcast in the link addresses all types of cancer.
"Dramatic enough" results can lead to approval for treatment even from a modest sized phase I study in a serious disease with only a single arm study held up against a historical control. (Start slightly before the 54 minute mark through 55 minutes 23 seconds.)
If you look at the timing for approval on recent cancer drugs, they've been getting approved in "4 months much less 6." (Start at 45 minutes 58 seconds.)
Robert J. Temple
Deputy Center Director for Clinical Science
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
DMD Webinar
February 20, 2013
Hi Ou,
One thing I was wondering about was that there was no mention of a systemic response. Will they need to inject every tumor? Can't there be a lot of them in one patient? How would that affect the cost of the treatments? -- Ou
Funny you should mention that. I contacted 5 major media conglomerates today. I think they will be glad they started researching this story now, because they need a fair amount of time to do background research. Linda Liau, her UCLA peers, Bosch, Bonynton, Linda Powers, patients, critics, dendritic science, etc. I am looking forward to Ken Burn's special next spring. If he starts following NWBO now, I think it will be his crowning achievement. Patients everywhere rejoice!
Upgrades around the corner?
Flashback.
ā¦.I can foresee Direct being approved in the 15 - 30 month window. Those inoperable patients need help, and the FDA wants to help them. I think the speed could even surprise me. May 30, 2014
Congratulations NWBO!
Immunotherapy results getting stronger for DCVAX-Direct. Background research literature suggests this trend will continue.
āAs of the 3rd injection in week 2 of the treatments, we now have 65% of the patients (13 of 20) showing some positive effects, and as of the 4th injection in week 8 of the treatments, we now have 100% of the patients (9 of 9) showing some positive effects." -- NWBIO June 11, 2014
I think we can assume that all 5 main cancer types in the trial have had a response, and at least one "other." NWBO does not say this yet, but it seems quite logical.
Thanks Hodge! Miraculous!
If NWBO partners, I hope they select well.
I have nothing against Russia, but one concern would be a company there might already be encroaching on NWBO patents -- I'm not certain about this, and it is in the vast random facts flying around in my brain.
TEVA is extremely large and NWBO functions very well in Israel, so that may be a natural fit -- again, I'm not certain. Anyway, I think there is a match out there that could reduce many concerns for investors and NWBO. Mostly it should be a partner that can globalize this technology rapidly, make it available to the masses and yet still thrive.
RRR, I should add, the perfect match might become a global force. If trial results continue on track, that partner could quickly help NWBO acquire a wish-list of hopeful startups. Bosch and Boynton probably know every promising dendritic company out there.
I would like to see a partnership with a major Asian Pharmaceutical. It would fund our US/Europe efforts, allowing us to continue in our primary and secondary markets as an independant entity and give us what we need in the east. -- RRR
LTT said:
Food for the sharks and the shorts - flipper meat
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Can anyone locate Credit Suisse AG's complete buy/sell history on NWBO?
Another way AF actively hurts NWBO: Trial Enrollment.
For the last 6 months on Google, if you are a new patient or investor and you search the word DCVAX or DCVAX-L the first or second web news article you will come across is by AF.
Why Northwest Bio's DCVax Brain Tumor Vaccine Will Blow Up Just Like ImmunoCellular's ICT-107 A. Feuerstein December 17, 2013
"Cancer Patients Aren't Responding to Northwest Bio's DCVax-Direct" AF May 27, 2014
So it appears Dresden is "open for enrollment". -- Eval
The first German site is now starting to screen patients for purposes of enrollment, and the additional German sites will begin doing so following their scheduled initiations (patients can obtain information about trial sites by contacting the Company at patients@nwbio.com ). -- NWBIO June 10 PR
Speaking of which, I've been off the grid for a few days. Did Highwayman get a reply from LG? -- Astavakra
Just like the clinic openings, I think the first successful reimbursement negotiation will be a template for the rest -- even with the differences from site to site.
Excellent clarification and summary. I really did not think about Paraxell, and must admit I also got a sense that NWBO was impatient regarding clinic openings.
It appears the 1 new site in Dresden is included on ClinicalTrials.gov, so that must mean 10 other new trial sites just opened elsewhere (in the US? or perhaps also in UK? .... might need to do some digging). -- Evaluate
I'm kind of interested in what RedBaron thinks about all this.
He waited so long for this day. Years.
I'm certain he will want to hear that the first patient was treated, reimbursement resolution and so forth, BUT,
Red, more than anyone else, saw clinic openings in Germany as the primary bottleneck for everything else.
Well, I think NWBO's failure to educate and hold press conferences probably causes your sentiment. Nobody likes to be told about "luxury" in the same sentence as expanding the trial. Nobody likes to be told "actively considering it" and "a little bit" unless we are told clearly, what this might look like, that they do not have pfs knowledge -- even though they said this earlier and it is part and parcel of phase 3 trials.
Investors want to know why Linda could make predictions about DMC recommendation timelines 6 months ago, but now she apparently can't.
I want to know if Sitiain is correct -- that Germany will be able to enroll due to reimbursement requirements.
Nonetheless, this is good news.
1. It means Germany is manufacturing DCVAX-L for Germany and Europe (in addition to Great Britain), treating patients with DCVAX-L and paying for DCVAX-L.
2. It means the price negotiations are very near completion, because they need to pay reimbursement fees for patients starting therapy.
3. It means that the rest of Europe will then be able to calculate their reimbursement levels, using Germany's price as a keystone.
4. It means NWBO is a trailblazer that now is an expert in moving into a foreign market that has a high barrier to entry.
5. It means revenue.
6. It means the intrinsic value of this company is moving higher each day, not just due to ongoing direct information and possible L results, it has more value because of its incredible infrastructure and
ramping capabilities.
I think there was a sense at NWBO, who are on the inside looking out, that this would be a greatly anticipated happy surprise (timing wise) -- meaning great progress; but from the outside looking in, without prior investor education, the delay caused unnecessary anxiety that could have been quelled quite easily with the same press release 2 months ago minus the actual clinic opening news yet explaining the delay.
That is a very big deal Hodge.
Note: While I do not subscribe to the full enrollment theory before AA interim analysis is allowed, let's assume AVII is correct -- and assume Sitiain is also correct re: you can only get treatment if you enroll in the trial or are not accepted into the trial (in Germany).
These clinic openings could move enrollment forward very quickly, and therefore get us to full enrollment more quickly, and therefore allow AA much sooner, under AVII's theory.
You are missing something, but I can see why.
First, Doctor Gorter has been conducting therapy using this technology in Cologne. From all indications, he falls/fell under an exemption clause, much like many of our clinics do when they conduct small trials -- like the Triozzi study -- however, Gorter had a continuing -- like -- exemption.
Other than that, yes, the clinics were approved but none were opened until the end of May. That is why people like myself and even critics likeā¦. were waiting for the first trial clinics to open. While I did not share the critic's cynicism, I shared some impatience (so did NWBO). Now we know why, once again, things take a while in Germany.
Another part that may have confused you is that Germany was already manufacturing DCVAX for people in Great Britain.
Sitiain, do you remember where you read this? (assuming you are talking about Germany/EMA)
If you qualify for the GBM trail you have to go on the trail. -- Sitiain
I'm headed out, but I think the subgroup numbers you quote may demonstrate why we should not take NWBO's pseudo progression group for granted. pspr responds well to dendritic trx.
Survey: Is the DMC analysis currently delayed/blocked due to "active consideration" by NWBO regarding trial size?
Feel free to respond with one word or many.
My Answer. I don't know.
How do you propose they did it? It was worked through with the FDA prior to restarting in 2011. An 8:5 ratio is not a variable day to day suggestion.