I really believe all the prior rules for establishing trials, etc. have been abandoned. PSTI should be able to get it's trial started sometime next month, if in fact a trial isn't already started in Germany, which may, or may not be expanded on.
Until coronavirus has been resolved with vaccines and/or therapeutics, and no longer considered a threat, forget business as usual. Look at what they're doing with remdesivir, could you imagine such use if things were being done in a normal way. It would probably be years and many millions more in trial costs before such use would be permitted.
We know Gilead's trial was much larger than the few who've received PLX-PAD, but we also know that the numbers of deaths were only slightly improved. To date we've not had a death in the small number we've treated, all on ventilators, and I believe they're all now off ventilators, and most discharged from the hospitals. I would still love to see the compassionate use numbers grow to hundreds, or thousands, as I believe the results would be so positive you wouldn't have to wait on formal trial results. JMHO
Gary
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