Hello, any advice/suggestions/experience is appreciated as there are so many situations that are not clear.
Situation: submitting a CTA under CTIS. Submitted IMPD and cross-referenced the IB. Nonclinical data included in the IB was intentionally limited.
During RFI cycle, nonclinical questions were raised by Spain. While responding to these questions, would there be an expectation that the Sponsor would be required to update the IB to include this information? If yes, would that be a condition of CTA approval or is this something that could be submitted at a later time?
This is obviously time sensitive to any feedback would be appreciated! THANK YOU!
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C Wojtaszek
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