Monday, July 18, 2016 8:15:11 AM
"the great majority of NDAs receiving CRLs DO NOT eventually receive FDA approval"
And then the facts said:
"Complete response letters featured prominently in these reviews, Datamonitor found. One hundred and forty-six (42%) of all submissions received a CRL, of which 55% later obtained approval. Approximately a third of the submissions were withdrawn, while another 16% were still undergoing review by regulators."
ma·jor·i·ty
m?'jôr?de,m?'jär?de/
noun
1.
the greater number.
"in the majority of cases all will go smoothly"
synonyms: larger part/number, greater part/number, best/better part, most, more than half; More
Happy to educate!
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