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NorthWest Biotherapeutics (NWBO)

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Last Post: 12/20/2014 11:14:19 PM - Followers: 208 - 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

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 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

NWBO Analysis
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
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 - 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.


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: Current Report Filing (8-k) 12/15/2014 05:02:25 PM
NWBO News: Amended Quarterly Report (10-q/a) 12/12/2014 04:25:35 PM
NWBO News: NW BIO RECAPS 2014 PROGRESS, PROVIDES DCVAX-DIRECT TRIAL UPDATE AT OPPENHEIMER'S 25TH ANNUAL HEALTHCARE CONFERENCE 12/11/2014 11:59:00 AM
NWBO News: Current Report Filing (8-k) 12/02/2014 04:11:46 PM
NWBO News: Proxy Statement (definitive) (def 14a) 11/26/2014 04:08:42 PM
PostSubject
#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
#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
#27237   How is loaning the company 2.25 million and bjoel5150 12/20/14 11:14:18 PM
#27236   Quoting Steven, they can coexist. See his article Rkmatters 12/20/14 10:52:07 PM
#27235   SEC - Form 4 NORTHWEST BIOTHERAPEUTIC For: Jun Evaluate 12/20/14 09:43:49 PM
#27234   In the prior trial design/protocol, did the SSR Evaluate 12/20/14 09:39:19 PM
#27233   Plus: I do not think they will have Astavakra 12/20/14 09:36:03 PM
#27232   Is anyone concerned that Celldex just completed enrollment Smokey21 12/20/14 09:31:55 PM
#27231   Sept is end of enrollment. Rkmatters 12/20/14 09:29:25 PM
#27230   Ah, OK: so that implies that the final Evaluate 12/20/14 09:28:31 PM
#27229   I thought the Commercialization aspect was a portion Rkmatters 12/20/14 09:28:16 PM
#27228   Also, maybe the company issue isn't the halt Evaluate 12/20/14 09:20:32 PM
#27227   The Q&A portion is part of the Oppenheimer Rkmatters 12/20/14 09:16:54 PM
#27226   In the Q&A portion of the conference Evaluate 12/20/14 09:10:50 PM
#27225   The delays with L are discouraging, but there Ready4bluesky 12/20/14 09:10:12 PM
#27224   The Direct Ph IIs will likely enroll fast Evaluate 12/20/14 09:07:20 PM
#27223   Thats great thank you , for me Basin Street Blues 12/20/14 06:54:59 PM
#27222   I have read of multiple but forgot them Pyrrhonian 12/20/14 06:17:46 PM
#27221   Management's predictions come from initial trial design assumptions. Pyrrhonian 12/20/14 05:51:56 PM
#27220   This is all very novel and the only Pyrrhonian 12/20/14 05:48:07 PM
#27219   The DMC can make adjustments going forward but Pyrrhonian 12/20/14 05:44:44 PM
#27218   IMUC will not fail their next trial. They Rkmatters 12/20/14 05:27:15 PM
#27217   Thanks Regina , I have no doubt it Basin Street Blues 12/20/14 05:20:04 PM
#27216   Also, maybe the company issue isn't the halt Rkmatters 12/20/14 05:18:20 PM
#27215   BSB, I'm not the right person to answer Rkmatters 12/20/14 05:00:01 PM
#27214   It's positive if it ends early or on Rkmatters 12/20/14 04:53:17 PM
#27213   In an effort to gauge Linda's reasoning can Basin Street Blues 12/20/14 04:51:33 PM
#27212   if phase 2 direct results are exceptional, ie staccani 12/20/14 04:49:49 PM
#27211   Thanks. I'll read those. Can they skip an Rkmatters 12/20/14 04:47:02 PM
#27210   No but they have to update the clinical Pyrrhonian 12/20/14 04:41:05 PM
#27209   Also http://core.ecu.edu/psyc/wuenschk/StatHelp/Type-I-II-Errors.htm Pyrrhonian 12/20/14 04:39:07 PM
#27208   Hi Pyrr DrChuck 12/20/14 04:36:08 PM
#27207   As long as the placebo is indistinguishable from Pyrrhonian 12/20/14 04:31:59 PM
#27206   Thanks. That sucks. I hope they decide to Rkmatters 12/20/14 04:24:01 PM
#27205   They don't, as it has no impact on Pyrrhonian 12/20/14 04:17:30 PM
#27204   Definitely understand the weariness. Still, it's hard to Pyrrhonian 12/20/14 04:06:53 PM
#27203   A few more question: How easy is it Rkmatters 12/20/14 04:05:35 PM
#27202   I understand not being able to tell us Rkmatters 12/20/14 03:44:09 PM
#27201   Basin Well put and should be the foundation of JTORENCE 12/20/14 03:42:16 PM
#27200   Thanks Pyrr, Basin Street Blues 12/20/14 02:59:59 PM
#27199   No, that is absolutely unacceptable. It would immediately Pyrrhonian 12/20/14 02:37:00 PM
#27198   The AGM summary that was kindly posted by Basin Street Blues 12/20/14 02:28:09 PM
#27197   I don't think your interpretation is correct. They Pyrrhonian 12/20/14 02:18:51 PM
#27196   My post for today. flipper44 12/20/14 02:02:35 PM
#27195   Sorry, I posted this as a reply to beachlifeisfun 12/20/14 01:01:34 PM
#27194   beachlifeisfun 12/20/14 01:00:39 PM
#27193   Hey bluesky,my last investment of the year is Sub Atomic master 12/20/14 12:58:23 PM
#27192   Should be investing isn't gambling. Can't log Rkmatters 12/20/14 12:49:30 PM
#27191   P.s. Investing is gambling, it's work. Gambling is Rkmatters 12/20/14 12:48:26 PM
#27190   Thanks Ready, I've always been objective. Other points Rkmatters 12/20/14 12:42:31 PM
#27189   You really shouldn't use any four letter word Ready4bluesky 12/20/14 12:37:32 PM
#27187   I must say, I'm really digging this far Ready4bluesky 12/20/14 12:27:19 PM
PostSubject