Alois, Could you clarify what you mean by a "clinically...

Alois,
Could you clarify what you mean by a "clinically meaningful" improvement. I have only seen drugs approved by demonstrating a statistical significance.
Take the failed Neurochem trial in Canada for instance. The trial failed due partly to 30% of the placebo group showing improvement with patients taking the other currently available short term drugs. CEO Bellini was astounded when his drug failed. He had personaly put in $50m to the project. He said he had seen improvements in patients and knew it worked. He vowed to take it to market as a homepatic. He had seen meaningful improvements in patients in the clinic, but it meant nothing without without being able to demonstrate statistical significance, which so far PBT has.
Neurochem did not use the NTB test as an endpoint in their trials.
True to his word Bellini has changed the name of Neorochem to Bellus Health inc. Bellus has formed Ovos Natural Health. Ovos is marketing a natural product called Vivimind "to protect memory and other ageing problems". Maybe a bigger market than Alzheimers. Vivimind is the failed Alzhemed drug.
They recon it could find a $1Billion market niche.
Here is an independent review of Vivimind, and they really pan it due to the fact they were never able to demonstrate statistical significance.
http://www.businessethics.ca/blog/2009/04/vivimind-evidence-and-ethics.html
Nobody remembers the reasons the trial failed, why Bellini called it inconclusive, just that it didnt get the statistical significance, which PBT has already demonstrated.