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Posted On: 11/04/2019 11:00:13 AM
Post# of 149390
Re: DoubleBagger24 #10530
The phase 1 trial in 2005 only went to 5mg/kg, so 250mg for average 50 kg male. Normally phase 1/2 is where you find the safety dose range for the drug, if they had continued, as 300mg is still safe, they would have found 700mg safe. Then we wouldn't be here because Cytodyn would not been able to buy it off the shelf, they would have used the higher dose in phase 2 trials and gotten amazing results as we now do. The original studies had the correct half-life listed in one phase 2 study at 2 weeks, but then another sc study listed it incorrectly as 3.5 day. That would be critical in combo, because at 350mg dose, with a half-life of 10 days, there are just getting a fraction of the full dose in the study.
https://clinicaltrials.gov/ct2/show/NCT00110591
Higher doses wasn't attempted until this phase 3 investigatory trial, which wouldn't even have started without NP push for it. Because the phase 2 mono trail that cydy did came back with 350mg at 25% or 40%, I will have to check to final tally. The FDA said they must get it to 70% for approval, they didn't know about the higher dosing at that point. So no one else but NP thought it possible. He almost single handled willed mono into possibility, with some luck because he believed in leronlimab when no one else did. No even me. I didn't think mono would work a couple year ago, now I do.
https://clinicaltrials.gov/ct2/show/NCT00110591
Higher doses wasn't attempted until this phase 3 investigatory trial, which wouldn't even have started without NP push for it. Because the phase 2 mono trail that cydy did came back with 350mg at 25% or 40%, I will have to check to final tally. The FDA said they must get it to 70% for approval, they didn't know about the higher dosing at that point. So no one else but NP thought it possible. He almost single handled willed mono into possibility, with some luck because he believed in leronlimab when no one else did. No even me. I didn't think mono would work a couple year ago, now I do.
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