Off Topic- Secretin & FDA Great News!

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Repligen says has FDA Fast Track for autism drug

September 05, 2001 08:49:00 AM ET

NEEDHAM, Mass., Sept 5 (Reuters) - Repligen Corp. (RGEN) said on

Wednesday that the U.S. Food and Drug Administration has granted Fast

Track designation for its secretin drug used in the treatment of

pediatric autism.

Under FDA rules, a Fast Track designation means a product will be

reviewed in an expeditious manner if the drug is intended for the

treatment of a serious or life-threatening condition and it

demonstrates the potential to address unmet medical needs for such a

condition.

Autism is a serious developmental disorder characterized by defects in

socialization, communication and repetitive behaviors, which afflicts

500,000 people in the United States.

" We are very pleased that the FDA has designated this program for

Fast Track status, " stated Walter C. Herlihy, President and Chief

Executive Officer.

REUTERS

© 2001 Reuters