OHM, how?why? does the parceling of information fr
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Posted On: 09/23/2020 9:17:53 PM
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OHM, how?why? does the parceling of information from one agency to another after study completion, have any effect on the (efficacy) legitimacy of the study. -sean007
The FDA considers the DSMC to be untainted by commercial considerations and their conclusions to be more pure. Once data is turned over to the sponsors or associates - In an interim analysis the data may be shaped to promote a better outcome. If it is not approved on interim and proceeds to the end then the sponsor or doctors may influence the rest of the trial directly or indirectly based on the unblinded data.
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And it likely has little to no bearing on LLMab needing to have a Long Hauler study. "Heterogenous" means not everyone is going to respond the same way (why IncellDX's diagnostics will no doubt feature heavily). -JLANG
They are not even positive of the cause of longhauler's syndrome. Is it viral shedding, has another factor caused auto immunity, is it something else? Dr. Yo and Dr. Paterson's targeted approach based on individual chemokines and indiviualized treatments using specific drugs could become a mess. 3 different cytokine elevations, 3 different drugs, 3 different adverse events profiles. Not to mention drug interaction.
Knowing the cytokine profiles is very important, specifically targeted treatment not so much. Leronlimab with it's stellar safety profile has a very good chance of fixing it all. Until leronlimab is approved and production is ramped up there will be no choice but to throw the kitchen sink at it.
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