NO FOREIGN POLICY OBJECTION TO FDA-937-07 GRANT

UNCLAS BERLIN 001279 SENSITIVE SIPDIS PLEASE PASS TO FOOD AND DRUG ADMINISTRATION, OFFICE OF INTERNATIONAL PROGRAMS: ELAINE C. FOSTER E.O. 12958: N/A TAGS: TBIO FDA GM SUBJECT: NO FOREIGN POLICY OBJECTION TO FDA-937-07 GRANT REF: STATE 93064 ¶1. (SBU) The U.S. Embassy in Berlin finds no negative U.S. foreign policy implications for the proposed award of FDA Research Grant Entitled "Phase 2/3 Study of FX-1006A for Familial Amyloid Polyneuropathy." The Embassy understands that this grant began in 2007 and that there are already ten patients involved in the study in Munster. ECONOFF spoke with the research professor who confirmed that the rights and welfare of the human subjects are being protected and that the monitoring plan to ensure data integrity is also good. Professor Hartmut Schmidt said that this was the first drug of its kind and that his patients are already benefitting from it. KOENIG