Ann: EU Marketing Authorisation Application Revie, page-2

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