We have no idea what the FDA or Mayo input was or how much of that input is actually used in the India "study" plan or if the plan is still being followed. Per MK, the Indian physicians are improvising. Does it even matter? Very clear they can't even do a competent phase 1 safety study remotely, let alone phase 2. They need operations near human trial to test the product they intend to market.
Maybe there's Indian investors that can bail out RDGL to get competent trials going? The dilution will suck, but what other choice is there? At moment RDGL needs more cash to set up operations in India or they need to abandon this "trial".
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