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NorthWest Biotherapeutics (NWBO)

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Last Post: 3/29/2015 2:19:53 PM - Followers: 236 - Board type: Free - Posts Today: 18

 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

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)

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)

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)

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

NWBO Analysis
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 Press Releases 
NWBO Yahoo Headlines

UK News Coverage
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

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

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

Research Posters
SITC 2014 - Direct
ASCO 2014 - Direct

Stock Quote & Summary
As of November 17, 2014

Common Shares Outstanding:   76,861,294
Warrants Outstanding:               35,509,555
Convertible Debt:                         2,479,000
Options Outstanding:                   1,551,000
RSU's Outstanding:                                   0*
Total Fully Diluted Shares:       116,400,849

(*Note: RSUs authorized and issued Nov 12, 2014: 10,577,176 (5 years vesting based on service and performance conditions). None are vested yet. Anticipate adding 528,859/qtr beginning next quarter to reflect a straight line amortization estimate)

Beneficial Ownership of NWBO Common Stock held by: 
All executive officers and directors:                            40,382,602 
5% Security Holder – Toucan Partners, LLC:              4,105,474 
5% Security Holder – Cognate BioServices:             29,899,143 
5% Security Holder – Dennis Mehiel:                          4,105,843 
Total (@9/30/2014):                                                   78,493,062 

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
"Proffered Paper:  Prolonged Survival for Patients with Recurrent Glioblastoma Multiforme who are Treated with Tumor Lysate-Pulsed Autologous Dendritic Cells" - ITOC-Conference, Munich, Germany - March 26, 2015, 14:40 - Marnix Bosch, Chief Technical Officer, NW Bio (note, abstract linked here is from Science Direct and will be the subject of the discussion)
"DCVax®: Novel Pesonalized Immune Therapies for Solid Tumors" - World Vaccine Congress 2015, Washington D.C. - April 9, 2015, 10:25 a.m. ET - Linda Powers, CEO, NWBO
AACR (American Association for Cancer Research) - Abstract Presentation - Monday April 20, 2015, 1:00 to 5:00 p.m. - "Clinical and immunopathological effects following Image-guided intratumoral injection of activated, autologous dendritic cells in patients with advanced solid cancers" - Abstract #2499
AACR - Abstract Presentation - Monday April 20, 2015, 1:00 to 5:00 p.m. - "Treatment with tumor lysate-pulsed autologous dendritic cells prolongs survival in patient swith recurrent glioblastoma mulitforme" - Abstract #2491

NWBO Presentation at ITOC2 Conference - March 26, 2015 - Webcast by Marnix L. Bosch, MBA, PhD, CTO, NWBO (sign up required)
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)
NWBO - Biotech Showcase 2015 Presentation - January 12, 2015 - Webcast by Linda Powers (sign up required)
Transcript of Biotech Showcase 2015 - provided by sentiment_stocks
NWBO - 2th Annual Oppenheimer Healthcare Conference - December 10, 2014 - Webcast by Linda Powers  (sign up required)
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)
Timeline of 25th Annual Oppenheimer Healthcare Conference - provided by Evaluate)

NWBO Linda Powers Presents at SMi 3rd Cancer Vaccines Conference 2014

A MUST SEE (sign up required):
Linda Powers Announces England's 1st PIM (Promising Innovative Medicine) Designation and Recent Progress to Date 
and gives a Good Explanation of how DCVax Works.

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

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Current Price
Bid Ask Day's Range
Option Chain for NWBO
NWBO News: NW Bio To Present At The 2nd Immunotherapy Of Cancer Conference, ITOC-2 03/24/2015 10:42:00 AM
NWBO News: Sonic Corp. Is A Terrific Stock - Cramer's Lightning Round (3/19/15) 03/20/2015 05:04:08 AM
NWBO News: Annual Report (10-k) 03/17/2015 09:51:26 AM
NWBO News: Notification That Annual Report Will Be Submitted Late (nt 10-k) 03/16/2015 05:22:38 PM
#31649  Sticky Note A few of NWBO Webcast slides from near TheFollower 03/26/15 10:49:09 AM
#30941  Sticky Note Regarding RECIST and the P1 Direct Trial… sentiment_stocks 03/17/15 03:40:36 PM
#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
#31957   If it were me, IMHO, I would not flipper44 03/29/15 02:19:53 PM
#31956   OMG, an extraordinary invasion of the body. I dpinvest 03/29/15 02:06:18 PM
#31955   Morningstar keeps a very active list which you john1045 03/29/15 01:55:46 PM
#31954   After the initial 2-3 injections, Direct is probably flipper44 03/29/15 01:46:34 PM
#31953   What proportion of cancers have Cytomegalovirus? 1%? dpinvest 03/29/15 01:41:47 PM
#31952   They should inject it every day, maybe every dpinvest 03/29/15 01:13:53 PM
#31951   Such a ridiculous accusation, has no place on dpinvest 03/29/15 12:58:53 PM
#31950   This NIH paper speaks to the lymphatic trafficking Rkmatters 03/29/15 12:58:43 PM
#31949   http://www.nasdaq.com/symbol/nwbo/institutional-holdings#ixzz3ALUutOjt Papa Tweek1 03/29/15 12:56:54 PM
#31948   Why not just look it up? Go to Ready4bluesky 03/29/15 12:19:44 PM
#31947   Does anyone have the institutional shareholder list they Pip611 03/29/15 12:14:08 PM
#31946   With the 1st interim analysis projected to be Ready4bluesky 03/29/15 11:53:00 AM
#31942   Quite absurd this posting about Pyrr being a Anhe 03/29/15 08:02:28 AM
#31941   You are correct on big pharma doing this. Doc x 4 03/29/15 06:43:32 AM
#31939   You may be right. I imagine it will Rkmatters 03/28/15 02:19:02 PM
#31938   I agree Direct will likely invoke a higher flipper44 03/28/15 01:55:27 PM
#31937   I haven't listened to the conference yet. Maybe Rkmatters 03/28/15 01:50:26 PM
#31936   IMHO, it would be the other way around. flipper44 03/28/15 01:44:30 PM
#31935   Interesting, though I'm not sure a change to Rkmatters 03/28/15 01:26:21 PM
#31934   As they say Flip, timing is everything. Very Astavakra 03/28/15 12:51:10 PM
#31933   Yeah, but you're not talking about being vengeful Rkmatters 03/28/15 12:30:14 PM
#31932   Dosing schedule after commercialization of DCVax-L? flipper44 03/28/15 11:47:51 AM
#31931   From YMB post: DoGood_DoWell 03/28/15 07:43:52 AM
#31930   I would add that these German studies seem lunatick 03/28/15 06:51:30 AM
#31929   Also the Germans are researching immunotherapies against cancer lunatick 03/28/15 04:55:21 AM
#31928   Thank you for replying back. In my case BioInfo 03/28/15 04:18:19 AM
#31927   http://news.yahoo.com/video/immunotherapy-weapon-fight-against-cancer-232056187. tina12321 03/28/15 02:49:44 AM
#31926   Senti, Do Good and anyone else having the RRRichmond 03/28/15 12:34:49 AM
#31925   link for a story on this poliovirus: mapman1010 03/27/15 07:53:20 PM
#31924   Duke again. Full story on 60 Minutes this sunday mapman1010 03/27/15 06:59:13 PM
#31923   Another brain cancer therapy using Polio vaccine on mapman1010 03/27/15 06:33:17 PM
#31922   I checked with i-hub and I'm told the sentiment_stocks 03/27/15 05:42:16 PM
#31921   How do you know? That's what I love vator 03/27/15 05:30:27 PM
#31919   Same thing happens when I'm on my phone. sentiment_stocks 03/27/15 05:13:19 PM
#31918   Thank you so much. I am working from DoGood_DoWell 03/27/15 05:01:27 PM
#31917   Hi Pyrr, H2R 03/27/15 04:49:21 PM
#31915   Did anyone see this on CNN, CNBC or mapman1010 03/27/15 03:55:45 PM
#31913   For eliminating Pop-ups try this for Internet Explorer. TheFollower 03/27/15 03:50:29 PM
#31912   Dumb tweet interesting article; austinmediainc 03/27/15 03:45:52 PM
#31911   Agree. :) Rkmatters 03/27/15 03:40:51 PM
#31910   Hey man I get where you are coming austinmediainc 03/27/15 03:35:49 PM
#31909   Well, the point of my rhyme wasn't so akasidney86 03/27/15 03:24:31 PM
#31908   I obviously meant "other hand". Really busy Rkmatters 03/27/15 03:23:02 PM
#31907   I appreciate Linda's explanations. I love her sentiment_stocks 03/27/15 03:19:27 PM
#31905   The chemo era will be viewed as The CaptainOblivious 03/27/15 03:09:58 PM
#31904   Well you should definitely by a bunch of Ready4bluesky 03/27/15 03:03:14 PM
#31903   So here's my view of the Bosch data akasidney86 03/27/15 03:01:34 PM
#31902   The graphs from the presentation look pretty good vator 03/27/15 02:47:35 PM
#31901   Pyrrh, so you became more sceptical about Direct. Anhe 03/27/15 02:46:18 PM
#31900   I vote we have CEO start and finish Homework.Investwell 03/27/15 02:44:59 PM