By this stage of the investigation quite a considerable amount of work has already been done in relation to the new drug candidate. We have an early view that it can be made by a feasible chemical route and that the necessary raw materials are available to a requisite standard of purity. We know also that the new compound has distinct effects in normal and abnormal intact animals and also in various isolated tissue and biochemical preparations. What we do not yet know is how safe it is or alternatively how toxic it might be following chronic administration to either animals or man.
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