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Posted On: 09/29/2019 7:16:41 AM
Post# of 150405
I just found something, that made me feel a lot better about it. There phase 2b that started in 2008, which took them 6 years or more to complete plus an additional phase 3. I was’t aware of the first trial taking so long until I did some digging and no one has mentioned it before on iHub or here. So it took them 10+ years to get approval from that trial. Leronlimab had just to do the one phase 2b/3 trial, so likely 5 years to approval from trial starting.
https://clinicaltrials.gov/ct2/show/NCT00784147
They also did a loading dose to get around the half-life issue. That had to greatly help their primary endpoint. Could you imagine what a 2000mg dose of leronlimab would do to viral load week 1?
“After a 7-day control period in which patients continued to receive their current therapy, a loading dose of 2000 mg of ibalizumab was infused; the viral load was quantified 7 days later. Through week 25 of the study, patients received 800 mg of ibalizumab every 14 day“
https://clinicaltrials.gov/ct2/show/NCT00784147
They also did a loading dose to get around the half-life issue. That had to greatly help their primary endpoint. Could you imagine what a 2000mg dose of leronlimab would do to viral load week 1?
“After a 7-day control period in which patients continued to receive their current therapy, a loading dose of 2000 mg of ibalizumab was infused; the viral load was quantified 7 days later. Through week 25 of the study, patients received 800 mg of ibalizumab every 14 day“
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