NP said in the CC when they might file for the piv
Post# of 154119
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Posted On: 02/27/2019 7:01:39 AM
NP said in the CC when they might file for the pivotal trial. After they submit the first part of the BLA, which is already complete, and I am assuming ready to go, they will file for the pivotal trial.
Quote:
In regards to monotherapy, trial we are to present at CROI on march 4th. Our abstract was accepted and we are excited to go back to croi and say that our last trial that we presented at CROI that had only 40% responders rate, now is change and there with a seven hundred milligram we have much better data and 525 milligram.
So that we will follow through but we are working on our pivotal trial and once we submit our first part of our BLA which is already complete one third of a non-clinical section then we will follow with our protocol for a monotherapy pivotal trial
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