No you don’t ;) If you are stuck in the “every approach has to be tested to conventional FDA standards” then yes. If you are able to look outside the box for a

No you don’t ;) If you are stuck in the “every approach has to be tested to conventional FDA standards” then yes. If you are able to look outside the box for a little then you will realise that you don’t. This is not a problem that is going to be solved by old thinking.