Identifier
Created
Classification
Origin
08BERLIN1279
2008-09-17 13:21:00
UNCLASSIFIED//FOR OFFICIAL USE ONLY
Embassy Berlin
Cable title:
NO FOREIGN POLICY OBJECTION TO FDA-937-07 GRANT
how-toVZCZCXYZ0006 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
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
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