Replies to post #9783 on NorthWest Biotherapeutics Inc (NWBO)

[sentiment_stocks]

Adam F should have read this part of your recent post:

However, true surrogate endpoints capture the full treatment effect of a drug, and the FDA requires only that endpoints for accelerated approval be “reasonably likely to predict clinical benefit.” The endpoints most commonly used for accelerated approval include progression-free survival (PFS) and objective response rate (ORR (1, 17)... Progression-free survival is generally defined as the time from randomization or treatment initiation until tumor progression or death. It usually allows a shorter follow-up period and smaller sample size than studies measuring overall survival (OS), and is not confounded by the impact of subsequent therapies. In diseases such as renal cell carcinoma, PFS is accepted as an established surrogate for OS and can be used as the basis for full approval (1)

[Evaluate]

Pyrr

Your link led me to this link:

http://clincancerres.aacrjournals.org/content/19/14/3722.abstract

Use of Multiple Endpoints and Approval Paths Depicts a Decade of FDA Oncology Drug Approvals
Michael B. Shea, Samantha A. Roberts, Jessica C. Walrath, Jeff D. Allen, and Ellen V. Sigal
+ Author Affiliations

Authors' Affiliation: Friends of Cancer Research, Washington, District of Columbia
Corresponding Author:
Samantha A. Roberts, Friends of Cancer Research, 1800 M Street NW, Suite 1050 South, Washington DC 20036. Phone: [phone]; Fax: [phone]; E-mail: [e-mail]
Abstract

This study explores the historic use of different endpoints to support regular and accelerated approval of cancer drugs between 2002 and 2012. In the past 10 years, two thirds of oncology regular approvals were based on endpoints other than overall survival. More than three quarters of accelerated approvals were based on response rates. The accelerated approval program has been heavily used over this time period, with one third of all approved oncology indications receiving accelerated approval. At times, critics have characterized the agency as rigid and unpredictable. This research describes the degree of regulatory flexibility that U.S. Food and Drug Administration and drug sponsors have used over the past decade in the development of new treatments for cancer. Clin Cancer Res; 19(14); 3722–31. ©2013 AACR.

Received February 1, 2013.
Revision received April 11, 2013.
Accepted April 30, 2013.

[terry hallinan]

Thanks for bringing this paper back up, Pyrrhonian.

I had read it before and struggled with this obvious half-truth and forgot all about the document's origin and most everything else:

Regardless of the setting, new therapies should be shown to have at least comparable activity to existing treatments for the existing treatments for the particular stage of disease. This pathway-based distinction recognizes our increasing understanding of cancer as a genetic disease

Page 7
http://clincancerres.aacrjournals.org/content/early/2013/04/03/1078-0432.CCR-13-0315.full.pdf

Japanese women immigrating to the U.S. and eating an American diet will have an increased chance of breast cancer but a lower chance of stomach cancer.

There are no gene transplants at the border and Japanese women, like all women everywhere, are not clones of each other.

The beneficial and carcinogenic parts of the Japanese diet are reputedly seaweed and pickles, respectively.

Having recently tasted authentic Japanese seaweed soup as opposed to some Americanized version, I can see why women would prefer breast cancer. :-(

Until the FDA sets aside the ubiquitous racist ideology that is worldwide, the enormous benefits possible from genetics are going to be minimal at best and sometimes downright dangerous IMO.

As every damn fool knows the Irish are mainly good at fighting and drinking. My son Pat thinks he is Irish like his immigrant grandfather, with the same name oddly enough. :-)

Pat fought one boxing match with a Navy amateur with a very lengthy and excellent record and some 35 pounds heavier in the heavyweight class. After the bout, his opponent told Pat that Pat hit very hard. Pat said all he could remember hitting very hard was the floor, over and over.

Pat perhaps has more genetic markers originating in Ireland than, say, Barack Obama but Pat most certainly has more Viking genes than Irish genes and not from the valiant efforts of the Vikings to disperse their genes but from the home country even before it was a country.

It would be helpful to look at the genes instead of the sociologists doing mythological social constructs.

Do you know why the Vikings never saw werewolves and vampires and leprechauns?

The answer is most surprising:

http://www.damninteresting.com/bad-rye-and-the-salem-witches/

It's not so much the rye they guzzle in D.C. perhaps but the rye they eat. :-)

Best, Terry