가입 후 초대 링크를 공유하면 동영상 재생 및 초대 보상을 받을 수 있습니다.

Shanaka Anslem Perera ⚡
@shanaka86
Author of The Ascent Begins. Independent Analyst. Money, geopolitics, AI, science, and sovereignty. Trying to understand the reality a bit better.
가입 July 2009
3.6K 팔로잉 중    307.6K
On 5th November 2019 a pivotal trial of the kidney drug avacopan missed. The two sided p value was 0.1025. Four days later a ChemoCentryx executive emailed a colleague, “We cannot afford to miss a superiority outcome here.” The FDA set out the rest in a notice dated 27th April 2026. Company staff searched the unblinded data and picked nine patients whose scoring could be revisited, six on avacopan and three on placebo. On 13th November, before any re-scoring was requested, a company executive asked an outside statistical consultant to rerun the analysis on what the notice calls “a hypothetical dataset accounting for the anticipated results.” It assumed five of the six avacopan patients would flip to remission and none of the placebo three would. He replied that the new p value showed statistical significance. The re-scoring went out the next day. It came back exactly as the hypothetical had assumed. Five of six avacopan patients flipped. No placebo patient changed at week 52. The FDA notes that no week 52 change was requested for them. The database locked again on 20 November at p 0.0132. Approval followed in 2021. The New England Journal of Medicine retracted the paper on 29th June. The European Commission revoked the European licence on 4th August. Health Canada has told doctors not to start new patients. Britain and Australia are reviewing. TAVNEOS is still sold in America. Amgen bought ChemoCentryx in 2022, three years after the conduct described, strongly disagrees with the FDA, and has asked for a hearing. Second quarter sales were $150 million. Amgen carries $2.4 billion of TAVNEOS rights on its books, $2.3 billion of it American. At 30th June it had written off none of it.
더 보기