re: filing of ind in the us Pharmaxis files Aridol IND in the USA:
http://stocknessmonster.com/news-item?S=PXS&E=ASX&N=350565
Extract:
"Alan Robertson, Pharmaxis chief executive officer said that the filing of the IND was an important event in the continuing globalisation of Aridol: “The recently completed Australian Aridol trial allows us to apply for marketing authorisation in Europe and Australia.
This study has been designed to extend our authorisation to the American market,” he said.
“The filing of the IND represents the culmination of a significant effort by very many people and is indicative of the quality and expertise of the team we have assembled.
The results from this trial and the recently completed, successful Phase III Australian trial will form the basis of a marketing application to be submitted to the FDA in 2005.” said Dr Robertson.
The Phase III clinical trial will be conducted over ten sites in the US and will recruit 130 subjects. The objective of the trial is to determine sensitivity and specificity of Aridol with respect to clinical diagnosis of asthma".
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