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NorthWest Biotherapeutics (NWBO)

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Last Post: 7/4/2015 12:26:28 PM - Followers: 248 - Board type: Free - Posts Today: 0







 Stylized Dendritic Cell

A "personalized brain cancer vaccine, DCVAX, is the first of its  kind and... is on the road to FDA approval."
- Neil A. Martin, Chairman, UCLA Department of Neurosurgery


Abstracts
"Clinical and immunopathological effects following Image-guided intratumoral injection of activated, autologous dendritic cells in patients with advanced solid cancers" - Abstract #2499 - AACR (American Association for Cancer Research)
"Proffered Paper:  Prolonged Survival for Patients with Recurrent Glioblastoma Multiforme who are Treated with Tumor Lysate-Pulsed Autologous Dendritic Cells" - presented at ITOC-Conference, Munich, Germany - March 26, 2015, 14:40 - Marnix Bosch, Chief Technical Officer, NW Bio (note, abstract linked here is from Science Direct)

Corporate Profile

NW Bio is developing cancer vaccines designed to treat a broad range of solid tumor cancers more effectively than current treatments, and without the side effects of chemotherapy drugs.  NW Bio’s proprietary manufacturing technology enables them to produce its personalized vaccine in an efficient, cost-effective manner. NW Bio has a broad platform technology for DCVax dendritic cell-based vaccines.

Their lead product, DCVax-L, is currently in a 348-patient Phase III trial for patients with newly diagnosed Glioblastoma multiforme (GBM), the most aggressive and lethal brain cancer.  This trial is currently underway at 69 locations thoughout the United States, Germany and the United Kingdom. NW Bio has also conducted a Phase I/II trial with DCVax-L for late stage ovarian cancer together with the University of Pennsylvania.

Their second product, DCVax-Direct, is currently in a 60-patient Phase I/II trial for direct injection into all types of inoperable solid tumor cancers, with trials currently being conducted at both MD Anderson Cancer Center in Texas, as well as Orlando Health in Florida.  

 They previously received clearance from the FDA for a 612-patient Phase III trial with its third product, DCVax-Prostate, for late stage prostate cancer.
 



Clinical Trials
DCVax®-L to Treat Newly Diagnosed GBM Brain Cancer (NCT00045968) - Phase III (Double Blind) 
Expanded Access Protocol for GBM Patients with Already Manufactured DCVax®-L Who Have Screen-Failed Protocol 020221 (NCT02146066) (Expanded Access)
Safety and Efficacy Study of DCVax-Direct in Solid Tumors (NCT01882946) - Phase I/Phase II (Open Label)
UK Clinical Trials - Study of a Drug (DCVax®-L) to Treat Newly Diagnosed GBM Brain Cancer
EU Clinical Trials for DCVax-L - Phase III

Company Contact Info
Investor Relations:
Les Goldman    (Co.)     (202) 841-7909  lgoldman@nwbio.com
Farrell Kramer (Media)  (212) 710-9685  farrell.kramer@mbsvalue.com or media@nwbio.com

Company Headquarters
4800 Montgomery Lane, Suite 800, Bethesda, MD 20814  (240) 497-9024

DCVAX Survival Stories
NWBO - National Geographic's Allan Butler Stage IV Pancreatic Patient using DCVax-Direct at MD Anderson
NWBO GBM Brain Cancer Survival Story of Mark Pace
NWBO GBM Brain Cancer Suvivial Story of Brad Silver
NWBO, GBM Brain Cancer Survival Story of Mike Gregoire
UCLA - Real Stories Using DCVax

Designations & Awards
German Hospital Exemption (referred to as HE) Information for DCVax-L® - FIRST TIME EVER

DCVax-L Hospital Exemption Program Now Under Way in Germany (NWBO, PR Newswire, October 14, 2014)
Two German Approvals:  "Hospital Exemption" for Early Access Program with DCVax-L and Eligibility of DCVax-L for Reimbursement (NWBO, March 10 2104)
Analysis:  NWBO DCVax-L German Approval Under Hospital Exemption Early Access Program (Smith on Stocks, Nasdaq, March 11, 2014)
Exclusive - Germany OKs Northwest Bio Brain Cancer Drug, Shares Soar (Ransdell Pierson, Reuters, March 10, 2014)

FDA Endpoints & Approval Information
House committee approves bill to speed new drugs to market - May 21, 2015 (Toni Clarke, Reuters)
FDA could approve drugs fro new uses on less data:  draft law - April 29, 2015 (Toni Clarke, Reuters)
Richard Pazdur says FDA racing approvals due to unprecedented efficacy - April 15, 2015 (BioCentury TV)

United Kingdom Awards DC-Vax-L® as Promising Innovative Medicine (PIM) - FIRST TIME EVER
First UK "Promisting Innovative Medicine" Designation Awarded (Department of Health and George Freeman MP, Gov.UK, September 16, 2014)
NWBO's Cancer Vaccine is the First Drug to be Designated by UK Authorities as a "Promising Innovative Medicine" (PIM) - (NWBO, September 16, 2014)


Immunotherapy Index
Loncar Investments - Cancer Immunotherapy Index - follow how NWBO is weighted in this Index of 25 Immunotherapy Companies

Immunotherapeutic Niches, Competition and Collaboration (5 Parts)
Part III - Immunotherapeutic Niches, Competition and Collaboration. Immunomodulation - Anti-CTLA-4MAb (Prepared by flipper44, December 2014)
Part II - The Cellular Approach (Prepared by flipper44, November 2014)
Part I - Vaccines  (Prepared by flipper44, November 2014)

Interviews
Linda Powers Interview 5-15-12

Important or Helpful Links
NWBO Stock Quote & Information
NWBO SEC Filings
NWBO Twitter
NWBO Facebook
NWBO Yahoo Message Board

Upcoming Healthcare Conferences

Institutional Investments
Nearing "the finish line" on cancer vaccine trial, Maryland firm raises $40 million - April 3, 2015 (J.D. Harrison)
Northwest Biotherapeutics:  The $40 Million Woodford Financing is A Major Positive - April 3, 2105 (Smith on Stocks - Larry Smith)


NWBO Analysis
Northwest Biotherapeutics:  FDA Panel Recommendation to Approve Amgen's Cancer Vaccine is Hugely Significant In Regard to Possible Approval of DCVax-L and DCVax-Direct - May 1, 2015 (Smith on Stocks - Larry Smith)

Northwest Biotherapeutics:  Promising New Data Was Just Presented on DCVax-L in Recurrent Glioblastoma Mulitforme - March 27, 2015 (Smith on Stocks - Larry Smith)
Northwest Biotherapeutics:  How Much Will it Cost to Manufacture DcVax-L - March 5, 2015 (Smith on Stocks - Larry Smith)
The Potentially Key Role of Northwest Biotherapeutics in the Emerging Immuno-Oncology - February 3, 2105 (Smith on Stocks - Larry Smith)
Notes from Linda Powers Presentation in San Francisco - January 12, 2015 (Smith on Stocks - Larry Smith)
Current Investment Recommendations for Stocks Covered by SmithOnStocks; A Yearend Review - December 19, 2014 (Smith on Stocks - Larry Smith)
NWBO discussed at great length.
NWBO:  Putting Recent Clinical Data on DCVax Direct in Perspective - November 28, 2014 (Smith on Stocks - Larry Smith)
DCVax-L:  A Reimbursement Perspective - November 22, 2014 (Seeking Alpha - Ryan Pawell)
DCVax-Direct Validation and Updated DCVax-L Ph III Modeling - November 6, 2014 (Seeking Alpha - Steven Giardino [Pyrr])
Now is the Time for Northwest Biotherapeutics - October 29, 2014 (Seeking Alpha - Steven Giardino (Pyrr)
U.K. May Grant Early Patient Access for DCVax-L Priot to Formal Approval  - September 18, 2014 (Seeking Alpha - Larry Smith [Smith on Stocks])
Exciting News on Potential for Early Patient Access for DCVax-L in the UK - September 17, 2014 
(Larry Smith, Smith on Stocks)
The Data Monitoring Commitee Addresses the Status of the DCVax-L Trial - August 13, 2014 (Seeking Alpha - Larry Smith [Smith on Stocks])
Cancer Vaccines:  Northwest Biotherapeutics -vs- Dendreon - July 15, 2010 (M.E.Garza, BioMedReports)


NWBO News
NWBO Press Releases 
NWBO Yahoo Headlines

UK News Coverage
NW Bio Announces $40 Million Financing - Further Equity by Woodford Funds April 2, 2015
Woodford's new biotech could be the next Amgen November 26, 2014 (Gavin Lumsden, Citywire Money)
Neil Woodford invests £16m in brain cancer vaccine company November 19, 2014 (Ashley Armstrong, The Telegraph)

NWBO - Short Seller Rebuttals and Information
Washington Post - Pulitzer Prize Winning Steven Pearlstein addresses NWBO and Short Selling
Citizens for Responsibility and Ethics in Washington (CREW) Requests SEC Investigate Manipulation of Drug Company Stock Price to Benefit Short Sellers
My Dialogue with Adam Feuerstein on Northwest Biotherapeutics - September 25, 2014 (Larry Smith, Smith on Stocks)
Jim Cramer Explains How the Stock Market is Manipulated - sounds a bit like some of the techniques used here.


Patent Information
Espacenet Patent information for NWBO
Patentdocs - Patent applications for NWBO
NWBO Receives U.S. Patent on Broad Processes for Producing More Potent Dendritic Cells - March 18, 2013 
NWBO's Patent Portfolio is Further Expanded with Manufacturing Automation Patent - September 10, 2013
NWBO Receives Approval of US Patent for Cost Saving Automation of High-Concentration DCVax Manufacturing - December 4, 2009
NWBO - Wikiinvest Intellectual Property - from the 10-K filed April 15, 2008

Patient Info
Prospective patients may contact NW Bio at patients@nwbio.com

Reports
Orphan Drug Report 2014  (EvaluatePharma, October 2014 - see page 14 ) 

Research Posters
AARC April 2015 - Prolonged Survival in Patients with Recurrent Glioblastoma Multiforme Who are Treated with Tumor Lysate-Pulsed Autologous Dendritic Cells
AARC April 2015 - Clinical and Immunopathological Effects Following Image-guided Intratumoral Injection of Activated, Autologous Dendritic Cells in Patients with Advanced Solid Cancers
SITC 2014 - Direct
ASCO 2014 - Direct

SEC Reports
Form 10-K - For fiscal year ended December 31, 2014

Stock Quote & Summary
As of May 6, 2015 

Common Shares Outstanding:   76,889,028
Options Outstanding:                   1,551,000
Convertible Notes:                       2,343,000
Share purchase warrants:          28,330,000

Total Fully Diluted Shares:       109,113,028


Beneficial Ownership of NWBO Common Stock held by: 
7.12% Security Holder – Toucan Partners, LLC:                         5,142,201 
37.95% Security Holder – Cognate BioServices:                      30,638,661
5.87% Security Holder – Dennis Mehiel:                                    4,125,949
11.23% Security Holder - Woodford Investment Management   7,896,675

Total (@12/31/14):                                                                     47,803,486 

Shares of common stock beneficially owned assumes the exercise of all options, warrants and other securities convertible into common stock beneficially owned by such person or entity currently exercisable or exercisable within 60 days of September 30, 2014.

52-Week High - (as of November 14) $10.64
52-Week Low - (as of  November 14)  $3.20

Transfer Agent:  BNYMellon Shareowner Services
520 Pike Street, Seattle, WA, 98101
Equity Holding customer service representatives are available from 9:00 a.m. to 7:00 p.m. Eastern Time,
Monday through Friday. Call +1 800 522 6645 (U.S. & Canada).

UCLA Department of Neurology
UCLA Chair of Neurosurgery Neil A. Martin, M.D., FAANS - Welcome Letter
DCVax in 4th paragraph - "on the road to FDA approval"

A Personal Quest to Cure Brain Cancer - (Into The Brain and Beyond by UCLA Neurosurgery)

Upcoming Events

Webcasts
ASCO 2015 - Overview of DCVax Direct Phase 1 Trial - May 30, 2015 - Webcast by Marnix L. Bosch, MBA, PhD, CTO, NWBO (YouTube)
   Slides presented in ASCO presentation to accompany Video
NWBO Virtual Investor Conference - May 7, 2015 - Webcast by Linda Powers, CEO, NWBO (sign-up required)
NWBO Presentation at ITOC2 Conference - March 26, 2015 - Webcast by Marnix L. Bosch, MBA, PhD, CTO, NWBO (YouTube)
NWBO Presentation at BIO CEO & Investor Conference - February 9, 2015 - Webcast by Linda Powers
NWBO Presentation at Phacilitate Immunotherapy World 2015 - January 26, 2015 - Webcast by Linda Powers (YouTube)
Transcript of Biotech Showcase 2015 - from January 12, 2015 - provided by sentiment_stocks
NWBO- 25th Annual Oppenheimer Healthcare Conference - December 10, 2014 - accompanying Slide Show
Transcript of 25th Annual Oppenheimer Healthcare Conference - provided by RK (Includes Q&A at the end)
NWBO Linda Powers Presents at SMi 3rd Cancer Vaccines Conference 2014 - Linda announces England's 1st PIM (Promising Innovative Medicine) Designation and Recent Progress to Date and offers an excellent explanation of how DCVax works

Websites
NWBO Company Website
Wiki page for NWBO
Informative Investor Website
Immunology Acronyms

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NWBO
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Option Chain for NWBO
NWBO News: Undervalued and Underexposed NYSE-MKT Stock to be Profiled by Large Media Group and four brief reports 06/15/2015 07:00:00 AM
NWBO News: /C O R R E C T I O N -- Northwest Biotherapeutics, Inc./ 06/01/2015 11:44:00 AM
NWBO News: NW Bio Announces Data to Date From DCVax®-Direct Phase I Trial 06/01/2015 10:33:00 AM
NWBO News: NW Bio To Present Overview Of DCVax-Direct Phase I Trial In Chicago This Weekend 05/27/2015 08:30:00 AM
NWBO News: NW Bio To Present At New York Academy Of Sciences' Conference On Emerging Approaches To Immunotherapy 05/21/2015 10:56:00 AM
PostSubject
#36574  Sticky Note THE TOPIC HERE IS NWBO TOB 06/16/15 04:34:50 PM
#36355  Sticky Note I had the pleasure of meeting Alice,Sarah,Dan and DoGood_DoWell 06/13/15 12:12:32 PM
#35731  Sticky Note NWBO in today's UK Times Supplement: TC_Trader 06/04/15 06:24:54 AM
#30450  Sticky Note Forbes Article: Northwest Biotherapeutices Is a Best Idea sentiment_stocks 03/10/15 01:06:44 PM
#22663  Sticky Note SA Article: DCVax-Direct Validation and Updated DCVax-L Ph Pyrrhonian 11/06/14 04:17:55 PM
#37141   It takes more than money to have a sentiment_stocks 07/04/15 12:26:28 PM
#37140   Tushay! DoGood_DoWell 07/03/15 08:09:35 PM
#37139   Funny I thought we retail investors were providing HappyLibrarian 07/03/15 07:10:07 PM
#37138   I believe they were only highlighting people who DoGood_DoWell 07/03/15 05:53:04 PM
#37137   Good to hear! We'll see what happens. HappyLibrarian 07/03/15 05:41:23 PM
#37136   I always assumed it was "pay to play" HappyLibrarian 07/03/15 05:39:00 PM
#37135   They are heeding your advice, and Les will DoGood_DoWell 07/03/15 05:30:33 PM
#37134   There was active effort to keep them from DoGood_DoWell 07/03/15 05:26:21 PM
#37133   Fair enough. HappyLibrarian 07/03/15 04:57:20 PM
#37132   That's a good beer to ponder NWBO with TZOR 07/03/15 04:55:05 PM
#37131   True. I was using drumbeat relative to the Know-Fear 07/03/15 04:52:07 PM
#37130   People are naturally skeptical of purported breakthroughs in HappyLibrarian 07/03/15 04:47:27 PM
#37129   The drumbeat is more like one or two HappyLibrarian 07/03/15 04:38:09 PM
#37128   I agree with that. If NWBO magically appeared Astavakra 07/03/15 03:47:35 PM
#37127   Agreed. Did not intend to imply they'd scale Know-Fear 07/03/15 03:47:14 PM
#37126   I would be surprised if gear was moved vator 07/03/15 02:50:20 PM
#37125   Not as much of a stretch as some Know-Fear 07/03/15 02:33:56 PM
#37124   Sentiment has been a headwind to NWBO. ScrtKnight 07/03/15 01:47:47 PM
#37122   Excellent choice sir. flipper44 07/03/15 12:32:26 PM
#37121   Great for NWBO to be mentioned, even if Astavakra 07/03/15 12:30:45 PM
#37120   Macrophages C. I'd like a Black Butte Porter as my NWDR 07/03/15 12:19:38 PM
#37119   I don't know. Sounds like a stretch. flipper44 07/03/15 11:32:28 AM
#37118   Finally get a mention. More will come in vator 07/03/15 11:32:16 AM
#37117   In Sawston I think you'll have NW employees Know-Fear 07/03/15 11:21:28 AM
#37116   http://www.fool.com/investing/general/2015/07/02/3-experimental-cancer-drugs-inv ScrtKnight 07/03/15 11:06:57 AM
#37115   Tomorrow is the Fourth of July. The market flipper44 07/03/15 11:00:44 AM
#37114   We are stuck at 415k shares traded, it afford567 07/03/15 10:55:36 AM
#37113   Today's pop quiz. flipper44 07/03/15 10:48:09 AM
#37111   Interesting. I eagerly await the phase II flipper44 07/03/15 09:41:59 AM
#37109   They have been performing a lot together lately.... DoGood_DoWell 07/03/15 05:56:46 AM
#37108   Need to put some production capacity into Sawston Know-Fear 07/03/15 03:21:32 AM
#37106   Yep. I think we can all relate to flipper44 07/03/15 02:21:51 AM
#37105   I agree 100% but the way it looks, TC_Trader 07/03/15 01:32:16 AM
#37104   I continue to hold good thoughts for your flipper44 07/02/15 11:53:25 PM
#37103   Hi TC, flipper44 07/02/15 11:49:42 PM
#37102   Cognate activity, Flipper what do you think about this: http://insideri.com/162 TC_Trader 07/02/15 11:18:25 PM
#37101   Good point, it'll be interesting to see what happens. HappyLibrarian 07/02/15 10:06:10 PM
#37100   I'm sorry to hear that your spouse has beartrap12 07/02/15 08:42:40 PM
#37099   My spouse is a cancer patient and the moneyfrog 07/02/15 07:26:02 PM
#37098   LP stated a while back that reaching the flipper44 07/02/15 06:00:37 PM
#37097   You must be expecting a halt for efficacy HappyLibrarian 07/02/15 05:10:39 PM
#37096   Excellent! I'm glad to see one of HappyLibrarian 07/02/15 04:57:39 PM
#37094   Moneyfrog. who is your source for info on beartrap12 07/02/15 04:51:38 PM
#37093   They have not started recruiting at all for moneyfrog 07/02/15 04:36:50 PM
#37092   IMHO they do not have phase II of flipper44 07/02/15 04:14:28 PM
#37091   Flipper, you don't think it's possible that they've beartrap12 07/02/15 04:08:04 PM
#37090   Thanks, John. TheFollower 07/02/15 03:40:21 PM
#37088   And just for clarification, the change at clinical flipper44 07/02/15 03:33:25 PM
#37087   The slight difference from KPS 60 (AKA: ECOG flipper44 07/02/15 03:18:38 PM
#37086   Direct Trial on clinicaltrials.gov Updated on June 28th john1045 07/02/15 03:13:56 PM
PostSubject