Agreed Titus
The FDA summary analysis I assume this thread is based on (Has anyone read the whole document?) is for a whole population - Europe rejected this - and only gave approval for those over 18.
If the article quoted several posts back is correct, the effect on the 18+ group will be being obscured and reduced by the 12-18s.
Curious PXS didnt just apply for 18+ approval (is it even able to this after trial design?) - a better chance of success may rest on their ability to request the committee to look at just the 18+ group if it isnt happy with the data on the whole population (again no idea of the ability to do this).
Fingers cross.
Simon
Agreed TitusThe FDA summary analysis I assume this thread is...
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