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Posted On: 05/04/2019 5:22:57 PM
Post# of 150024
I remember during a CC last year, someone asking NP since 700mg was so great, are they going to switch combo to 700. NP said, no, that would require another study, they want to get combo approved. But we say what happened with the FDA saw the data, luckily they didn’t require a new study.
So, I’m just speculating here, but maybe what happened is this. NP said 3 weeks ago the mono pivotal is ready to submit. Maybe they only had 700mg to make it faster since we know it has 70%+ success rate currently. They also made a pr about the density test. Maybe the FDA looked at the data and said, no the 525mg looks great after 10 weeks, 95% successful. You need to look at the failures before 10 weeks vs the successes after and figure out why, maybe with the density test. Then include both 525mg and 700mg in the pivotal study.
Again just speculation, but it seems the FDA never allows the quick path, they always want the ultimately best final result to be at the end of the first path.
So, I’m just speculating here, but maybe what happened is this. NP said 3 weeks ago the mono pivotal is ready to submit. Maybe they only had 700mg to make it faster since we know it has 70%+ success rate currently. They also made a pr about the density test. Maybe the FDA looked at the data and said, no the 525mg looks great after 10 weeks, 95% successful. You need to look at the failures before 10 weeks vs the successes after and figure out why, maybe with the density test. Then include both 525mg and 700mg in the pivotal study.
Again just speculation, but it seems the FDA never allows the quick path, they always want the ultimately best final result to be at the end of the first path.
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