“the FDA agreed to look at a pivotal clinical tr
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Posted On: 03/20/2020 1:09:45 AM
“the FDA agreed to look at a pivotal clinical trial and consider that for final approval after the first approval so it will be expanded label.”
Does this mean CYDY can/will attempt to use the most recent Mono trial of 550+ patients to file for a label extension? Or does CYDY still need to conduct another 48 week, costly Mono trial and then file for label extension?
Does this mean CYDY can/will attempt to use the most recent Mono trial of 550+ patients to file for a label extension? Or does CYDY still need to conduct another 48 week, costly Mono trial and then file for label extension?
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