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Posted On: 06/11/2022 9:21:06 PM
Post# of 145876
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Re: chazzledazzle #124605
Quote:
I don’t think with 7 patients in disparate stages of disease that we have concluded 700mg is less effective than 350mg.
Correct. A dose escalation should be incorporated in a phase 3 trial.
With such small patient populations there are many factors that could have affected those differences between 350mg and 700mg. The biggest difference between the two is PDFF which of course would also affect cT1 scores negatively in 700mg. That cT1 still improved in 700mg even with an increase in PDFF shows the strength of leronlimab's anti-fibrosis capabilities.
With 350mg and 700mg ran by different companies there would obviously be differences between how the trials were run. It could come down to something as simple as the company that Dr. Recknor chose having doctors tell the patients it's beneficial to limit caloric intake and Amarex not doing so. Knowing the weight of patients at the start and end of the trial in each arm might give us a clue.
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