Heaven help the company if they don't get the instructions right a second time. How could they get it wrong again after spending from memory a further $150 000 to make sure people can follow a set of instructions!
However, in the Bot video after the denial of approval, it was stated the only thing outside not getting the instructions correct that could affect approval was a change in the safety profile of the drug. For example, something goes unexpectedly wrong in the Japanese market with an adverse event.
This has not happened so I view approval as a formality and there won't be excited jumping up and down on here when it arrives from me
It is going to be much more exciting watching the sales figures track north in the coming years.
Heaven help the company if they don't get the instructions right...
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