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Re: humble howard post# 150455

Saturday, 03/06/2021 9:11:45 AM

Saturday, March 06, 2021 9:11:45 AM

Post# of 232167
No we didn’t reach our endpoint that is true. However 24% increase in mortality is far and away better than anything else we have for this particular area as it relates to covid19. According to the FDA’s guidelines Leronlimab should easily be approved. Let’s look at those details. If a therapeutic that shows more benefit than any downside and there is no other drug for this diagnosis, during a pandemic by there on admission it must be approved. We meet all of those criteria. Unless the FDA turns its back on the very rules that govern there actions . This is a new virus with that is easily and rapidly spread any and all treatments that improve mortality and get patients out of the hospital must be added to the toolbox. The severe to critical section of our box is empty at present. Leronlimab shows a far greater clinical significance than stat sig , even it’s stat sig is still 12 X better than the SOC. There is nothing else even close in this arena I would welcome a comparison, there is nothing that compares. I’m sure the families of the 500,000 people that lost the fight against this virus would have jumped at the chance for there loved ones to receive LL because 125,000 of them would still be here with us. Based on the FDA’s own writing this is a slam dunk for approval , saving lives is much more important than stat sig. We never needed stat sig for approval but don’t take my word for it , check it out under in the FDA guidelines. How much better is Leronlimab than Remdesivir?
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