A little thought experiment on efficacy and manufacturing.
Imagine you walking through the forest and you came across a unique liquid compound that you took to your lab and tested. Low and behold, it cured a previously thought of incurable disease, and without ill side effects. You repeated the trial again and again and came up with the same great results.
There was only one problem. You had no idea yet how to manufacture this strange compound.
Regardless, you submitted it to the authorities for approval for treatment for the incurable disease. How did they respond?
"Well Doctor, you have demonstrated its efficacy and safety, so your approval is granted on the basis that you can learn to manufacture it.'
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