Maybe read a bit further before posting?
"The CRL stated that the FDA is unable to approve the NDA in its present form based on the need for additional non-clinical information.
The Agency did not identify any clinical safety or efficacy issues or chemistry, manufacturing and controls issues. There are four non-clinical issues in the CRL, none of which relate to any observed toxicity.
The Company will request a Type A meeting to obtain agreement with the Agency and resubmit the application as quickly as possible."