Biotech Values

[iwfal]

GERN -

They were NOT talking about SAE, they were talking about regular AEs and lab abnormalities.

Fine, you can call them AEs - but coupled elevated Alkaline Phosphatase and Bilirubin at a rate of 4 out of 18 (or even, say, 2 out of 18 if, for instance, that is all they knew in Dec) is likely to garner more medical and/or regulatory attention than the same rate of Grade 3 AEs or even the same rate of reversible Grade 4 AEs.

That said, it isn't traditional Hy's law since it is Alk Phos and so there is some slack that can be cut. But in total this is probably the most serious (S)AE they have reported, and the claim that as of the ASH they hadn't seen the events is non-credible IMO.

BTW - I would suggest that this might be the explanation for why they dropped PV since even touching on the topic of Hy's Law issues at 1 in 10 chronic patients is something they might want to avoid (PV and ET being chronic diseases, AML being terminal, and MF somewhere in between).

Even though presentation was Dec, but data cutoff likely Oct. So it is possible they didn't know at that time, it is also possible they did, but may not as many patients as today.

Having watched multiple conferences I doubt that they would have had no opportunity to update after October for something important. And even if the data cutoff was Oct the math is not particularly credible as having seen none of the 7 and 4 events. Again, this goes to their credibility. And clearly, given the various analyst comments, I am not alone in this regard - although they are a little more fuzzy in their wording ('lack of clarity', ...).