...panelists questioned whether an even lower dose might be safer while still benefiting patients.
Panelists voted 20-5 that Novartis should be required to study a lower dose of the drug.
"I'm not convinced this is the lowest effective dose," said Dr. Donald Fong of Kaiser Permanente hospital network. "And if it's not the lowest effective does, then why should we accept this as the final answer for the patient?"
In a critical vote, the panel said Novartis could conduct the dose study after the drug reaches the market. A requirement to conduct the study pre-approval could have delayed a launch for years."
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