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TOPIC: NW Bio and Linda Powers with smashing news

NW Bio and Linda Powers with smashing news 10 Mar 2014 12:55 #1392

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I remember Linda Powers very well (Toucan Capital etc) - today they received excellent even sensational news...

- DCVax-L Is First Product of Its Kind to Receive Hospital Exemption from German Regulator
BETHESDA, Mayland, March 10, 2014 /PRNewswire/ -- Northwest Biotherapeutics (NASDAQ: NWBO) (NW Bio), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, announced today that it has received approval from the Paul Ehrlich Institute ("PEI"- the FDA of Germany) of a "Hospital Exemption" early access program under Section 4b of the German Drug Law. Under this Hospital Exemption, NW Bio may provide DCVax-L to patients for the treatment of any glioma brain cancers (both Glioblastoma multiforme and lower grade gliomas), both newly diagnosed and recurrent, outside of the Company's clinical trial and charge full price. The patients may be from Germany or elsewhere. This approval has a term of five years, and can be re-applied for and re-issued at the end of that period.

I assume Cytori knows this regulatory pathway too.... :whistle:

PR news on NW BIO
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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

NW Bio and Linda Powers with smashing news 10 Mar 2014 16:27 #1395

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As I understand now- NW Bio was a "client" of Fraunhofer- the gigantic research institute in Germany.

Since 2008 Cytori has a cooperation with Fraunhofer on stroke and it is known that the German government sponsors one or more of the studies being conducted in Europe.

So- dont be surprised if a surprise comes one fine day from Germany too. :winky:

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

NW Bio and Linda Powers with smashing news 10 Mar 2014 17:40 #1396

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With all these studies going onin Europe and many showing great efficacy it would be nice to see a goverment step up and offer reimbursement.Our therapy has to be much much cheaper than NW Bio althofugh thats a small indication. Insurance companies maystep up if it saves them money in the long term

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NW Bio and Linda Powers with smashing news 11 Mar 2014 05:53 #1397

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A truly great development in treating a disease that is quick, fatal and destroys patients in a terrible manner. To see the degeneration of the individual through the distruction of their brain is horrible.

At last a meaningful treatment that provides further validation for the belief that the effective treatments/cures for most of mankinds medical conditions are already within the patient. Cancer immunotherapy is not that far away from regenerative medicine as a concept........ the cure is within us. :happy:

As for Fraunhofer the realtionship has been ongoing for a very long time. The initial preclinical (animal) testing was to be for approx 2 years but almost 5.5 years have passed. In that time we have had further validation of ADRC's efficacy in a host of conditions. We have also seen trial data concerning BMSC treating stroke patients. Why the silence concerning Fraunhofer and Cytori???? :bash:

Fraunhofer continue to have the ADRC research prominent in their website. A long time has passed for them to still be dealing with animal models.

Lets not forget that stroke is a MUCH more prevalent condition that costs a lot more (financially & often emotionally) than brain cancer, which is relatively quick. If the Germans have been quick to finance NWBO then there is a very strong case for their funding ADRC treatment of stroke.

Fas, I won't be surprised if we get good news out of Germany, in fact I look forward to it ............. its just that I am getting impatient, particularly with the secrecy. Do you have any insight as to the nature of the trials being undertaken in Germany.......... I couldn't find anything. :cry:

www.izi.fraunhofer.de/ischaemieforschung-projekte.html?&L=1#c21701

ir.cytori.com/investor-relations/News/news-details/2008/cytori-selected-by-fraunhofer-society-to-develop-new-stem-and-regenerative-cell-based-treatments-for-stroke/default.aspx?print=1

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NW Bio and Linda Powers with smashing news 11 Mar 2014 06:28 #1398

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Joey-

All these "new innovative" procedures going thru clinics in Germany and getting "Hospital exemption" can also be reimbursed by the public insurances- actually I have a lot of documentation on that- but in German. :whistle:
The message yesterday gives a good idea how this works-

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.


John-

Do you have any insight as to the nature of the trials being undertaken in Germany.......... I couldn't find anything.

[/b]

Join the club- I have not found anything either. I am in touch with some experts in the field though (one is the department head at Fraunhofer of "Cell Engineering") but in southern Germany- the stroke app should come from Leipzig in the East) who tells me that a lot of applications are probably on the desk of the PEI (Paul Ehrlich Institute) in Germany, which is also the Competent Authority for Cell apps in this country. The legislation is from medio 2011 and I know for sure that Ken Kleinhenz was "in the thick of this"

My advice- lets just see what happens with other things at other places. The stroke app is sure to come in Europe too when the time is ripe. Its always good to have multiple large events coming. :vegas:

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NW Bio and Linda Powers with smashing news 11 Mar 2014 06:41 #1399

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And scleroderma is obviously something that can spread in no time from France to Germany.

As I have written before- the Germans are excellent in reducing health care cost and will jump at the opportunity.

Just anecdotal- when I had my "male tit" issue i.e. the puss under the nipple, which they cut open- I talked quite a lot with the female doctor at the gynaecology department (yes- I spent a day in a department of only women and babies, but in a private suite though.. :happy: )
She was very well informed about the Düsseldorf Breast Clinic and the breast reconstruction work done there (Cytori had training classes there done by German surgeons)
Folks know about the Cytori tech- shareholders of Cytori DO NOT. :cry:
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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:
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