Except that's not what happened with the MABs. They're all over the place with those - first a "no" then a "yes" then a yes, but only with this group", etc. They're human like the rest of us and will seriuosly consider a safer treatment - even if it's on the bubble ... out of desperation given nothing to date has come across that is safer and probably more effective.
"Regulators don't act out of desperation." WOW, talk about creating a strawman by exaggeration.
Regulators and governments do recognize unmet need. Various governments have created accelerated programs for cancer, Alzheimer's and other diseases because of unmet need. The US just created the CNVP program as an example.
A regulator being presented with data that looks good on its face for a drug that meets an unmet need and asking for the company to submit that drug to the approval process is responsible action on the part of the regulator.
The cost of AD care to health systems high and getting higher everyday. There is a desperate need for AD treatment. Regulators know that.
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