Overcoming a 
 Refusal to File For Your NDA

Read the story to learn how.

Imagine that your teams have been working at warp speed to finish your pivotal trial, standardize the data, and prepare your New Drug Application (NDA) for submission to the FDA. You achieve an aggressive timeline and get your NDA published on time.

You should be celebrating; however, the FDA responds with a Refusal to File letter.  

Learn how Veristat experts 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.

Download to case study to learn how.


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