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NorthWest Biotherapeutics (NWBO)

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Last Post: 1/30/2015 6:40:55 AM - Followers: 212 - Board type: Free - Posts Today: 3

 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
Farrell Kramer (Media)  (212) 710-9685 or

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
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
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

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
The 17th Annual BIO CEO & Investor Conference - February 9-10, 2015 - New York City

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

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Current Price
Bid Ask Day's Range
Option Chain for NWBO
NWBO News: NW Bio To Present At The 7th Annual Phacilitate Immunotherapy Forum 01/23/2015 01:06:00 PM
NWBO News: NW Bio To Present At Biotech Showcase Conference 01/08/2015 02:46:00 PM
NWBO News: Current Report Filing (8-k) 12/30/2014 08:02:45 AM
NWBO News: Current Report Filing (8-k) 12/29/2014 04:35:32 PM
NWBO News: Amended Statement of Changes in Beneficial Ownership (4/a) 12/22/2014 06:04:36 AM
#28276  Sticky Note BioTech Showcase 2015, January 12, 2015 Transcript sentiment_stocks 01/13/15 08:19:27 PM
#26533  Sticky Note Northwest Biotherapeutics – Linda Powers’ Speech Transcript at Rkmatters 12/14/14 06:53:48 PM
#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
#28805   If Provenge is worth $300 million the total vator 01/30/15 06:40:55 AM
#28804   BMY didn't develop checkpoint inhibitors by itself. investor_2013 01/30/15 02:59:46 AM
#28803   Because the only thing done at the enrollment longusa 01/30/15 01:09:34 AM
#28802   Wow! Valeant buys dendreons provenge! Here we go!!! Doc x 4 01/29/15 11:37:34 PM
#28801   We know from the enrollment interim and the austinmediainc 01/29/15 11:16:33 PM
#28800   Long, there's nothing 'potential' or 'may' about your akasidney86 01/29/15 08:17:05 PM
#28799   Yes, but even better, as pointed out by longusa 01/29/15 06:18:24 PM
#28798   Yes, more of the long tail will be longusa 01/29/15 06:11:34 PM
#28797   Also interesting is a recent story on FierceBioTech rrflyboy 01/29/15 05:52:41 PM
#28796   P.M. flipper44 01/29/15 04:34:18 PM
#28795   Thanks Long. So then the statistical point akasidney86 01/29/15 04:16:28 PM
#28794   The psPD 72 cohort of the original trial longusa 01/29/15 03:57:56 PM
#28793   I must say I'm still a bit Astavakra 01/29/15 03:49:35 PM
#28792   Long, thanks for the correction. That being the akasidney86 01/29/15 03:42:27 PM
#28791   Thanks. flipper44 01/29/15 03:21:40 PM
#28790   Re translator, go to home pg; translator longusa 01/29/15 03:20:45 PM
#28789   Flip, left you a PM on IV. longusa 01/29/15 03:18:55 PM
#28788   Thanks for further Google translating this. My flipper44 01/29/15 03:12:55 PM
#28787   Re CLDX-BMY, BPs have many many trials in longusa 01/29/15 02:33:58 PM
#28786   Make that rabid:) flipper44 01/29/15 02:28:15 PM
#28785   Sid, the 348 is comparable to the 240 longusa 01/29/15 02:25:34 PM
#28784   Thanks Luna. Very clear from the translations longusa 01/29/15 02:14:11 PM
#28783   Right. It's also why some rapid journalists flipper44 01/29/15 02:00:56 PM
#28782   He was talking about just ePD being placed flipper44 01/29/15 01:50:52 PM
#28781   Related to the previous thread about use of akasidney86 01/29/15 01:47:08 PM
#28780   PS where is the poster that said to austinmediainc 01/29/15 01:25:11 PM
#28779   Hi sentiment, lunatick 01/29/15 01:16:18 PM
#28778   Nope, but you'd actually have to read the austinmediainc 01/29/15 01:11:42 PM
#28777   I don't think Avastin is used in the sentiment_stocks 01/29/15 01:07:30 PM
#28776   There are other papers, looking at others techniques, austinmediainc 01/29/15 01:05:12 PM
#28775   My optimistic view, is BMY is picking partners Rkmatters 01/29/15 12:54:40 PM
#28774   Probably the link has already been posted. lunatick 01/29/15 12:53:13 PM
#28773   I agree...and they are tracked separately when in sd_investor_22 01/29/15 12:30:11 PM
#28772   Thanks Lunatick and Evaluate. This is helpful. flipper44 01/29/15 12:29:42 PM
#28771   Hi Eval, lunatick 01/29/15 12:16:23 PM
#28770   I believe if NWBO hasnt partnered on this Sub Atomic master 01/29/15 11:44:33 AM
#28769   Sure. You're the one giving the investment iclight 01/29/15 11:42:15 AM
#28768   They were looking for predictive factors in that flipper44 01/29/15 11:41:47 AM
#28767   Thanks Astavakra! flipper44 01/29/15 11:34:30 AM
#28766   For all the conversations relating to pseudo vs sd_investor_22 01/29/15 11:33:55 AM
#28765   I am up. Don't worry bout me. vator 01/29/15 11:31:22 AM
#28764   Nope, but you'd actually have to read the flipper44 01/29/15 11:29:34 AM
#28763   Sounds like a bunch of buying opportunities to me! iclight 01/29/15 11:24:53 AM
#28762   But I thought that's why LP was hanging iclight 01/29/15 11:21:11 AM
#28761   recognizes that true early progressors were the only austinmediainc 01/29/15 11:19:32 AM
#28760   You must be poor if you've been buying iclight 01/29/15 11:19:21 AM
#28759   Moreover, his steroid theory is logically self-defeating because flipper44 01/29/15 11:15:10 AM
#28758   If one catalyst or event doesn't pan out austinmediainc 01/29/15 11:13:35 AM
#28756   longusa said: - If the PhI data did Astavakra 01/29/15 10:53:05 AM
#28755   Potentially = on the fence. Years before flipper44 01/29/15 10:51:08 AM