Conference pretty positive..
- 8.3% Vs 5.7% pulmozyne against baseline is a fantastic result
- CF302 data will be provided to EU, strictly to satisfy saftey across awaide group for CE mark. no need to provide eficacy data.
- Meeting with FDA to discuss NDA application in September quarter and are confident the results (viewed along with CF301) will be taken well. Despite narrowly missing endpoint in mls, as a percentage it meets significance. Also those out of the USA were stronger than the average, ie dragged down by some of the latin american countiries where supplementary medical care would be less.
positive phase iii results, page-2
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