O+Y First Line Lung Application in Europe

What happened today with the Application pulled by BMS in Europe for O+Y for First Line Lung ? How will that effect the FDA Decision here in the US ?

 

It was a ballsy move but calculated nonetheless. The regulators had serious reservations about all the protocol changes midstream and were not going to approve it. With USA decision pending 5./31 they figured a “withdrawal” was less current to swim against vs. a flat out loss. Time will tell but they’ve got 4 months to try to shore things up,stateside.

 

A sinking ship

 

Calculated they said, ballsy they said.. it is pure desperation cause EU had enough with TMB nonsense.

 

Europe sucks, happy to let their own die rather than pay for effective treatments.

US review is completely unlinked, doubtful they would have granted priority review if they had reservations about study design.

 

Europe sucks? They have lower infant mortality rates in most of Western Europe compared to the US and higher life expectancy rates.