I received a response today from SPL.
Confirmation that the primary end point was NOT achieved for the study population (all ages).
Endpoints were, however, reached for the certain age cohorts >45yrs old.
So i hope this puts to bed the argument that the trial met its primary end points..... Because it did not!
If SPL only recruited patients 45yrs and older, then yes, it would have been a success, but they did not.
Obviously the data generated in the trial will be used to shape the marketing and commercialisation strategies moving forward.... Not sure what that looks like and whether any governing bodies would allow a product to be advertised as only being effective once you hit a certain age.....
We will wait ands see.
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