Let me give an analogy;
We are a car company, through all our own trials we are testing this funky new airbag for backseat passengers. In fact in all our tests (phase 1, 2) the data has shown that the number of backseat passengers admitted to hospital after an accident is 50% less!! But the other passengers in the front seat including driver show minimal if any difference.
So, lets go get approval from our friends at the FDA to save those backseat passengers with our funky new airbags which we have tested over and over again. FDA will be over the moon that we can save our backseat passengers.
And so phase 3 trial data is out; surprise, NO difference to hospitalization rates for backseat passengers with our funky new airbag. BUT hang on, there is suddenly a 60% reduction in deaths for the driver?!?! This is a complete surprise to our CEO (SI), never happened in all our previous trials. WOW, WOW, WOW pat on back, great result.
So now FDA should approve our funky new airbag that we expect to reduce hospitalization for backseat passengers (which in fact showed no difference) on the basis that the front seat passenger/driver had a 60% reduction in death... which of course is a complete surprise to our CEO as no previous data has hinted at this.
Fast forward to SH, we need to approve asap to save our Drivers with our backseat airbag! FDA can't ignore any longer.
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