biomed                                                                                      
Biomedical Research Institute of America
a non-profit corporation

June 7, 2002

Mr. Charles Wallach
Bio-Energy Services
18727 Ventura Blvd
Tarzana, CA 91356

Re:

Termination of Study
Bio-Energy Services, Inc
Protocol No. BDS PAP001

Dear Mr. Wallach:

The IRB committee has reviewed additional information regarding the above listed protocol. This information included data requested by the IRB and recently submitted by investigators involved in this study. The committee has also examined the web sites for Bio-Energy Services.

Upon review of this data at the June 5. 2002, meeting of the IRE, the committee unanimously voted to terminate approval for Protocol BDS PAP001 for all investigators. The reasons for this termination include;

Effective immediately, all research activity with this device must cease [21 CPR. 56.1 03 (a)]. In addition, you must remove the unapproved web site from the Internet immediately.

As the sponsor you are responsible for terminating the study at all approved sites. You are also responsible for the return or disposal of all study devices [21CFR812.7(e)].

If you have further questions regarding this issue, please feel free to contact our office.

Sincerely.

Edward Juskelis, M.D.  
IRB Medical Chairman    

copy: Mr. John Isele, CDHR/FDA             

This page was posted on December 3, 2007.

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