A multinational trial involving 20 sites involving a small patient population is not going to be simple, quick or cheap. Yes the need for an open IND for this trial will add another level of complexity and cost.
For those worried that I should be spending my time working on evaluating the new strategy rather than answering question here, you will be happy to know my notes have now reached 27 pages and I am not finished. One of the difficulties I face with this research is much of the important details in the new plan have apparently yet to be determined and so I am having to do a lot of research.
A multinational trial involving 20 sites involving a small...
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