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NorthWest Biotherapeutics (NWBO)

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Last Post: 11/28/2014 11:05:31 PM - Followers: 202 - Board type: Free - Posts Today: 80







 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)

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 I - Vaccines  (Prepared by flipper44, November 2014)
Part II - The Cellular Approach (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

NWBO Analysis
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
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
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)


Patent Information
Patent information 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

Reports
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)

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

A MUST SEE:
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.

Websites
NWBO Company Website
Wiki page for NWBO
Informative Investor Website
 

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NWBO
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Wiki
Option Chain for NWBO
NWBO News: Proxy Statement (definitive) (def 14a) 11/26/2014 04:08:42 PM
NWBO News: Quarterly Report (10-q) 11/19/2014 03:26:04 PM
NWBO News: NW BIO ANNOUNCES FINANCINGS TOTALING $35 MILLION TO EXPAND AND ACCELERATE DCVAX®-L AND DCVAX®-DIRECT PROGRAMS 11/19/2014 03:20:00 PM
NWBO News: Notification That Quarterly Report Will Be Submitted Late (nt 10-q) 11/14/2014 04:02:19 PM
NWBO News: Four Companies to Keep on Your Radar & Special Report on Emerging Beverage Contender by Small Cap IR 11/10/2014 07:00:00 AM
PostSubject
#23793  Sticky Note Key points of Dr. Prins interview. RRRichmond 11/17/14 10:21:34 AM
#23267  Sticky Note After brain surgery in 2005, neither Dr Liau Evaluate 11/11/14 05:19:08 PM
#22663  Sticky Note SA Article: DCVax-Direct Validation and Updated DCVax-L Ph Pyrrhonian 11/06/14 04:17:55 PM
#22136  Sticky Note THE TIME IS NOW FOR NORTHWEST BIOTHERAPEUTICS Diamondjim61 10/29/14 04:21:18 PM
#21296  Sticky Note DCVAX®-L HOSPITAL EXEMPTION PROGRAM NOW UNDER WAY IN GERMANY TOB 10/14/14 03:37:40 PM
#25205   Thanks Chiugray - fixed. sentiment_stocks 11/28/14 11:05:31 PM
#25204   Yes. My series limits itself to immunotherapeutic flipper44 11/28/14 08:34:29 PM
#25203   Sentiment, great. One minor item on the Chiugray 11/28/14 08:00:11 PM
#25202   Chiugray - Long - done. :) sentiment_stocks 11/28/14 07:51:17 PM
#25201   Long, Thanks. We're in agreement (your "2,450K Chiugray 11/28/14 07:21:52 PM
#25200   Hi Flip, KITE is also targeting CD19-expressing cancers longusa 11/28/14 06:40:59 PM
#25199   Woodford's new biotech could be the 'next Amgen' Evaluate 11/28/14 06:26:50 PM
#25198   I would assume since we are in Evaluate 11/28/14 06:14:52 PM
#25197   Thanks Maverick! Good to know that I am Evaluate 11/28/14 06:04:56 PM
#25196   I agree. I'm also not sure if anyone Rkmatters 11/28/14 05:58:26 PM
#25195   I'm antsy waiting on the mansion I was Evaluate 11/28/14 05:47:24 PM
#25194   Senti, Chiu, on the convertible debt, section 8 longusa 11/28/14 05:42:47 PM
#25193   PS I wholeheartedly disagree with the following statement Evaluate 11/28/14 05:13:42 PM
#25192   Eval, thanks for the great finds. I longusa 11/28/14 05:10:15 PM
#25191   Don't sweat it ic: csf_dialysis 11/28/14 05:00:57 PM
#25190   Yes, I actually saved a PDF version in Evaluate 11/28/14 04:50:39 PM
#25189   I just want to build a storage unit Pyrrhonian 11/28/14 04:37:38 PM
#25188   Haaa! That's pretty good.. Pyrrhonian 11/28/14 04:36:33 PM
#25187   I'm assuming you didn't clap along? :) sentiment_stocks 11/28/14 03:46:13 PM
#25186   Not grumpy. If I'm gonna be called iclight 11/28/14 03:43:56 PM
#25185   Grumpy Old Men famous on-liner: John Gustafson: "Pop, I'd Rkmatters 11/28/14 03:31:18 PM
#25184   You are probably right about the timing of laser777 11/28/14 03:28:17 PM
#25183   You seem grumpy ic, may I suggest: Pyrrhonian 11/28/14 03:14:46 PM
#25182   Believe it or not I'm not only here iclight 11/28/14 03:09:23 PM
#25181   Wow. I know you meant well but that Kap10jak 11/28/14 03:03:21 PM
#25180   While clinicaltrials is unreliable it is the location iclight 11/28/14 03:03:20 PM
#25179   Business concerns are translated into whining, and anything austinmediainc 11/28/14 02:33:49 PM
#25178   Thanks Chiugray (Long please read) - sentiment_stocks 11/28/14 01:59:59 PM
#25177   I would assume since we are in the AngeloFoca 11/28/14 01:43:36 PM
#25176   The last dose given for purposes of the flipper44 11/28/14 01:39:29 PM
#25175   Love the nose on that little one! sentiment_stocks 11/28/14 01:31:00 PM
#25174   New blog post by Woodford Funds. Very longusa 11/28/14 01:25:20 PM
#25173   I went back to look at the link DoGood_DoWell 11/28/14 01:24:25 PM
#25172   Happy Birthday Eval!! Evaluate 11/28/14 01:11:30 PM
#25171   Thanks everyone for the Birthday Wishes ... very kind. Evaluate 11/28/14 12:56:36 PM
#25170   IMHO L advanced DCs will be slightly more flipper44 11/28/14 12:53:25 PM
#25169   Evaluate, The common stock outstanding number we Chiugray 11/28/14 12:50:09 PM
#25168   It's funny ... when anyone mentions the word Evaluate 11/28/14 12:47:47 PM
#25167   New SmithOnStocks blog Etienne1 11/28/14 12:37:44 PM
#25166   And LP with her 39.2 Million beneficial share Evaluate 11/28/14 12:31:10 PM
#25165   Here's a little happiness for you Kap! sentiment_stocks 11/28/14 12:25:49 PM
#25164   CEO LP has, in my recollection of her maverick_1 11/28/14 12:21:46 PM
#25163   Thanks John - I posted it on the sentiment_stocks 11/28/14 12:20:41 PM
#25162   I wonder about this maturation process being more Pyrrhonian 11/28/14 12:19:34 PM
#25161   Yah. I guess do come here looking for Kap10jak 11/28/14 12:13:56 PM
#25160   When you combine this automation and cost reduction Smokey21 11/28/14 12:12:22 PM
#25159   Thanks. Possible further comparisons with the non-automated Provenge manufacturing: Pyrrhonian 11/28/14 12:07:53 PM
#25158   Nice find John. The resourcefullness on this Smokey21 11/28/14 11:59:54 AM
#25157   Ran across this by accident, Provides a bit john26632 11/28/14 11:51:48 AM
#25156   Happy Birthday Eval!! sentiment_stocks 11/28/14 11:45:12 AM
PostSubject