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Thursday, April 02, 2015 8:11:48 AM
Feuerstein forgot to mention that the information arm is being conducted by the same contract research organization that is doing the main Phase III trial.
Thus the only differences between the information arm and the main trial are:
The trial is not blinded.
The patients are sicker, on average than the participants in the main trial.
Unlike the main Phase III, this information arm has not been adjusted to account for the immune system damage caused by standard of care.
So, the last two points of difference actually make the results of this trial more compelling.
And I am not the only one to think so. I have a feeling that the Germans must have seen some early information on these patients before giving approval for Hospital Exemption.
Remember that we did not know the Information Arm existed until relatively recently but I am sure the Germans were getting that information earlier than we were.
Now we know that the Germans did not grant HE only on the basis of an old Phase 1 trial and that gives me even more confidence they are on to something.
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