Don’t forget, we get the application wrong, we miss something or we leave some detail out or something is misleading or contradictory - we are over, we are done. There is no second chance. This means we would need to then wait all the way till FDA gives commercial go ahead which could be up to 2 years from now before the TGA would look at us and potentially grant us a licence.
What I’m saying is that it is better they take their time with this and get it right. In my express view I very much feel this is the reason for the delay PLUS they are so busy getting the PRE IND out of the way.
Again in my humble opinion we just need to wait.
TGA, page-21
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