Replies to post #158469 on Biotech Values

[iwfal]

GERN - Quotes are from the quarterly cc:

With longer dosing, grade 1 increases in alkaline phosphatase were observed in 7 patients, associated with mostly grade 1 and in some cases, grade 2, unconjugated hyperbilirubinemia in 4 of the patients.

And later during Q/A:

The reason we're doing this [talking about SAE in the Quarterly CC] is because when we presented the data in December at ASH, we basically had to get the data, the pertinent data into 12 slides, and we focused largely on the efficacy data, the clinical responses, the molecular responses. I think we had 2 slides on safety, and I don't think that the 2 slides that we presented on safety did full justice to the clinical picture. We did present at ASH that there were rises in alanine transaminase and aspartate transaminase. And what we did -- what we have not observed at the time of the ASH meeting, and I think where your -- just to really get to the meat of your question, what we have not observed at the time of the ASH presentation were the increases in alkaline phosphatase that have been observed with chronic dosing.

Reminder - the ASH presentation on ET was 3 months ago, and the trial in ET had been enrolling for 24 months at that point. My guess is that the ET patient median time on trial was, at that point, about 10 months so I think it unlikely given the timing described above that they had seen none of the alkaline phosphatase or bilirubin issues in Dec and now have 7 cases of alkaline phosphatase and 4 of elevated bilirubin in the intervening 3 months. It is possible - but even with a company with a history of reliable transparency I would have doubts about such a wow-it-all-went-bad-at-once story