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Rukobia was approved for MDR in the summer of 2020

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Post# of 157752
(Total Views: 590)
Posted On: 07/26/2023 4:32:02 PM
Posted By: generactor
Re: Jake2212 #136232
Rukobia was approved for MDR in the summer of 2020 well before lenacapavir but lenacapavir was still approved on the basis of a small pivotal trial. I know there are differences between the two drugs but it was still only a 72 patient trial for lenacapavir that got them over the finish line.

The problem with our CD02 is it was even smaller with only 46 patients completing so that probably puts us back in the position of trying to integrate CD02 data with the monotherapy trial.

That's one of the lingering problems from the scattershot method of running trials.


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