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I don't understand very well your numbers , the 8

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Post# of 153939
(Total Views: 502)
Posted On: 11/04/2019 2:31:52 PM
Posted By: misiu143
Re: DoubleBagger24 #10535
I don't understand very well your numbers , the 81 is for combo, not mono,

In combo with 350 mg , efficacy was 81% which in my opinion was excellent , compare to 45% with Maraviroc and 43% with Ibalizumab...

The other numbers you talking I believe are with mono , and important numbers are the one with 4 weeks overlap now .

with 350 mg -after 38 weeks , with 4 weeks overlap is about 71% efficacy.
with 525 mg - after 31 weeks , with 4 weeks overlap , is 95% efficacy.
with 700 mg - after 20 weeks , with 4 weeks overlap , is 92% efficacy.

Those are great results , IMO no problem with approval.

It just FDA saw that results are better with higher than 350 mg dose , and making decision to approve combo with 525 or 700 mg.and was waiting for safety profile of 700 mg dose to give us final decision.

All this is also because they don't see even with higher dose any serious side effects.

So combo will be approved with 525 mg or 700 mg to what we know now ,
and mono patients will be treated according to Receptor Occupancy Test ,
Which actually I believe should also be done in combo , so lets see what FDA will decide at the end .









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