Cablegate: No Foreign Policy Objection to Fda-937-07 Grant

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RR RUEHWEB

DE RUEHRL #1279 2611321
ZNR UUUUU ZZH
R 171321Z SEP 08
FM AMEMBASSY BERLIN
TO SECSTATE WASHDC 2189

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

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