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Posted On: 07/12/2020 10:00:11 AM
Post# of 148908
Totally agree. The trial will provide the larger ‘N’ needed to get the statistical confirmation. This is the final nail in the proverbial .....
Having said that we already know from various presentations the “consistent” performance of Leronlimab in normalizing the hyper immune response and it’s effects, and now we have documented confirmation of this incredible viral load reduction to “undetectable” in only 14 days!
Projecting the these two results, immune normalization and viral suppression, which Remdesivir appears not to do effectively if at all, we should expect the mm trial results to be spectacular!
Regardless of whatever metrics you choose to measure as endpoints, we now know for sure that the Leronlimab patients are going to get much better and much FASTER than in the placebo arm! This will become the turning point for accelerated action as follows:
NP will request convening a independent “safety” review committee in the sc trial on the basis of the mm trial demonstrated safety, efficacy and correlation with BP’s disease progression of Covid-19. The data from these two trials with larger ‘N’ values on Leronlimab’s proven MOA in the medicated arms of both trials will immediately provide overwhelming evidence to stop the sc trial and provide Leronlimab to the poor suffering placebo patients immediately!
My guess is this will be the path NP will elect to take AFTER he discusses the mm trial results with the FDA. PROMPLTLY thereafter the FDA will allow it and then we will have the needed “UNMET MEDICAL NEED” clearance to get our lovely molecule approved!!
Having said that we already know from various presentations the “consistent” performance of Leronlimab in normalizing the hyper immune response and it’s effects, and now we have documented confirmation of this incredible viral load reduction to “undetectable” in only 14 days!
Projecting the these two results, immune normalization and viral suppression, which Remdesivir appears not to do effectively if at all, we should expect the mm trial results to be spectacular!
Regardless of whatever metrics you choose to measure as endpoints, we now know for sure that the Leronlimab patients are going to get much better and much FASTER than in the placebo arm! This will become the turning point for accelerated action as follows:
NP will request convening a independent “safety” review committee in the sc trial on the basis of the mm trial demonstrated safety, efficacy and correlation with BP’s disease progression of Covid-19. The data from these two trials with larger ‘N’ values on Leronlimab’s proven MOA in the medicated arms of both trials will immediately provide overwhelming evidence to stop the sc trial and provide Leronlimab to the poor suffering placebo patients immediately!
My guess is this will be the path NP will elect to take AFTER he discusses the mm trial results with the FDA. PROMPLTLY thereafter the FDA will allow it and then we will have the needed “UNMET MEDICAL NEED” clearance to get our lovely molecule approved!!
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