Overcoming an NDA Refusal To File
A Trusted Team of Submission Experts to the Rescue
Imagine that your teams have been working at warp speed to meet your NDA timeline and you finally complete the submission to the FDA.
You should be celebrating! But wait, the FDA responds with a Refusal to File letter.
It happens!
Learn how Veristat stepped in, performed an independent statistical review, explained the findings to the FDA, and helped the global pharmaceutical company fix the data to re-submit the NDA to the FDA.
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