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Posted On: 04/17/2019 11:14:59 AM
Post# of 153815
RE: 100 patients on 700 mg for safety data ...
The likely explanation, which finesand clearly avoids addressing, is that the mono pivotal protocol is important for combo BLA safety data, because the company had made the decision not to enroll any more patients at 700 mg in the investigatory mono trial in order to conserve resources.
So the already enrolled patients in the 700mg investigatory trial will count, but the company has stopped enrolling those patients to conserve resources for the mono trial and other purposes.
Total speculation on my part, but just my two cents that the truth is probably in the middle.
The likely explanation, which finesand clearly avoids addressing, is that the mono pivotal protocol is important for combo BLA safety data, because the company had made the decision not to enroll any more patients at 700 mg in the investigatory mono trial in order to conserve resources.
So the already enrolled patients in the 700mg investigatory trial will count, but the company has stopped enrolling those patients to conserve resources for the mono trial and other purposes.
Total speculation on my part, but just my two cents that the truth is probably in the middle.
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