Yes, Dr B of course the company must go through RCT's. That is a necessary part of the scientific pathway toward drug approval.
However, we are not scientists here but rather investors (gamblers if you will). We must be looking for a nexus between scientific progress and "breadcrumbs" left by speculating on and intertwining company actions and developments.
Because that is the principal method (such as it is) in attempting to assess value, and value is the yardstick to base investment on. [No good waiting until the horse has bolted - if in fact it is to bolt.]
And as far as I am concerned and as I have posted elsewhere, that time is NOW.
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