I am amazed that Benlysta got P3 approval given headline numbers like those. There must be more to their case than that surely. Or was the plight of Lupus sufferers so grim that ANY statistical improvement at that time would be welcomed with open arms?
On another point, the presentation talks of n = 200/study for Imm's P3 trial. But if one group is taking the active drug and the other is taking the placebo, isn't that 2 * 200 = 400 patients enrolled?
thanks, promising reading. o/t hope you and all your family are keeping well. Although post less frequently now I often check out your contributions. All without exception are informative and balanced. In any case atb and bonsoir mon ami
O&W rambling on a bit now and will take to the fields for a few more weeks but I did read that benlysta will be in the top 10 drugs for driving growth in the company between 2015 and 2020. It was expected to rise further after that date with increased revenue. Their calculations are not based on any other product being successful in that market.
Olderandiser, during P2 trials over 100 patients completed the 12 week course and over half completed a further 12 weeks. There were no reported adverse affects from the dosage and a decrease in the SLEDAI score. 12 being severe and 3 being mild. I think from memory the average reduction was five. That itself is significant and probably life changing from those suffering from lupus. Not sure why only half of them completed a further 12 weeks but would guess their fitness and condition had a… Read More
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