re: Ann: EU Marketing Authorisation Applicati... Lombard and others...
Does PXS *really* have a chance to get the EMA to reconsider the approval based on the same data set.
In plain black and white, EMA has said that 8% improvement
in FEV1 is not a significant improvement.
On the other side, TGA did approve the drug without too much fuss. I am assuming that TGA are not a bunch regulatory cowboys or are they?
Whats for certain is that the big reg organisations EMA/FDA dont really pay too much attentions to TGA decisions.
good luck holders.. I am still on sidelines at present
Ann: EU Marketing Authorisation Application Revie, page-2
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