Quote:So in mono ,
Final Results after 10 weeks , 525 were 95%’
And 700 mg upper 80,s or 90%,
And with time they changed for 700 mg to 92%...
I separated my response post into two for length. The FDA requested for mono in their letter to cydy after the phase 2 trial, that cydy find a group that had at least 70% efficacy. I'm not sure why 70% is the cutoff, I know it is when drug are approved. But if you are improving say even 50% of the lives of people staying on mono and the other 50% go back safety to haart, then it is only a gain.
Anyway, the FDA letter to CYDY stated 70%. They have that or higher with 525mg and 700mg when randomly assigned. So honestly I don't know why they even need an additional pivotal trial for mono. I could see the FDA wanting more safety data for mono at 700mg and 525mg (normal p3 trials approved has 500-1000 patients) and they have around 300, so I could see requesting addition patients for safety, but the efficacy requirement the FDA requested looks to be already met even before the new trial with the overlap and density test is added. But maybe that is why the FDA stated in their letter they intend to have mono approved, they just want the correct dose determined and possibly the extra patients for safety. We will see what the new mono pivotal trial looks like after the FDA meeting.
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