Vagenousis..... *smh* starting to make me doubt my university degree, thinking I must have missed learning about a disease at uni haha
But in all seriousness, a government organisation such as the FDA would have to have a valid reason to approve or reject applications, otherwise they leave themselves wide open to lawsuits. I'm interested to see what the reason was for their initial non-approval. There is no such thing as rejecting for no reason.
CRL or Approval???, page-52
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