Just got off the phone with Simon:
1, Simon confirmed that FDA does not require PAR to send back the response within 30 days. the 30 days stated in the previous announcement was meant PAR's estimated responding time.
2, Simon confirmed the response is well prepared and it is in the process of publication, which means the agent is doing final review to make sure all the links link to the right pages and etc.
3, Simon confirmed once the publication process is completed, the documents will be sent off to FDA. And I asked if it is fair to say that FDA should be available within a couple of business days. And Simon said yes
Since it was a verbal conversation, I do not have any attachment to prove what I said here. If people have doubt, please go ahead and communicate with Simon.
Simon has been very patient and helpful.
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- Ann: IND QUESTIONS RECEIVED FROM US FDA
Ann: IND QUESTIONS RECEIVED FROM US FDA, page-341
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