The point is- do not assume that the company will get TGA approval. Or, do not assume that even if and when they get approval they will get orders. The market has not assumed that approval and sales are a foregone conclusion. Just in the same way Otto should not assume that it would be a really good idea to have 98% of his super in one stock.
This is risk management. It is the difference between investing and gambling.
Something like that.
Ann: Director Share Sale To Institutional Funds Manager, page-23
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