You delay a TOX study if you don't yet have all the materials you need in order to conduct that TOX study. And then you build the production facility which will enable you to create the required quantities of the TOX materials, which they have now done.
If there were "issues with the toxicity of the drug" (which there are not) as you charge, then where is your evidence for such a claim? You have none, because there is none.
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