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Posted On: 07/12/2019 9:00:46 AM
Post# of 149717
Great point! With the density test data, just like with 700mg, the FDA will very likely require this now with Combo. Maybe give the same dose with Combo vs ccr5 density as they do Mono. (I always thought they were rushing the mono protocol before results came back from that test, but I guess the pressure to get something done won out over waiting)
So that means it is very likely they will need 700mg safety data for Combo. Which might change some questions slightly.
Combo/BLA
When will the 700mg safety data be complete?
Have you determined the dose vs Receptor Occupancy?
What is needed from the FDA before the BLA CMC part can be submitted?
Any response from FDA to our first part of the BLA?
Did the early discontinues in the placebo arm happen before steady-state? (pvalue for completed between groups <.02)
So that means it is very likely they will need 700mg safety data for Combo. Which might change some questions slightly.
Combo/BLA
When will the 700mg safety data be complete?
Have you determined the dose vs Receptor Occupancy?
What is needed from the FDA before the BLA CMC part can be submitted?
Any response from FDA to our first part of the BLA?
Did the early discontinues in the placebo arm happen before steady-state? (pvalue for completed between groups <.02)
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