Biotech Values

[biopearl]

jq, thanks for posting slide, I note the bilirubin elevation appears to be unconjugated does this not imply a cell lysis effect rather than hepatocellular failure? Also most lft abn classified as low grade and none met Hy's law. Also a board of expert hepatologists were said to have reviewed and passed on the data in question. Low grade lft abn seen w statins which usually resolve. FDA seems pretty concerned here even w hundreds of patients who have received drug (don't hold me to that number). Where's the red flag esp since patients have cancer some side effects might be outweighed by benefit esp if PR or CR achieved. TIA for the board's thoughts. Regards bp