funny games with xt's, page-8

re: re fda orpahn drug staus for cf Sydney - Wednesday - July 20: (RWE Australian Business News) -

Pharmaxis (ASX:PXS) announced today that the United States Food and Drug
Administration (FDA) had expanded the orphan drug designation for the
company's Bronchitol.
Bronchitol has been granted the additional indication of
facilitating mucus clearance in patients with cystic fibrosis.
The orphan drug status entitles Pharmaxis to a range of
incentives; these include a seven-year period of market exclusivity,
assistance from the FDA with clinical trial design and an exemption from
FDA User fees.
Many orphan products receive expedited review or accelerated
approval because they are for serious or life-threatening diseases.
Cystic fibrosis is a life threatening condition.
In February 2005, the FDA granted orphan drug designation for
Bronchitol as a treatment for patients with bronchiectasis.