1. Do we know that Dr.BP started measuring viral l
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1. Do we know that Dr.BP started measuring viral load with the first patient in both trials? I know that the pre-print of his manuscript contained Plasma Viral Load graphs. Just not sure every trial subject was tested and documented that way.Quote:
The viral load reduction would have been known before the trial started and the blood samples sent to IncellDX could have both serum and plasma separated for tests. So I have no doubt that was done.
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2. Is the FDA possibly so stringent in their submission regulations that there is facility for providing additional data points beyond what is officially included in the trial protocol?
Any additional data that can support conclusions in the trial can be added in a supplement.