Biotech Values

[iwfal]

GERN - Hold placed due to "the occurrence of persistent low-grade liver function test abnormalities observed in the Phase 2 study of imetelstat in ET/PV patients and the potential risk of chronic liver injury following long- term exposure to imetelstat."

This is consistent with my previously stated concern in the below thread:

#msg-85830649

In that thread I noted that I thought they were non-credible in their claims of why they didn't report the issue (not Hy's Law, but looks enough like it to be scary) earlier. We may now get to see more of the picture. Hopefully nothing significant went undisclosed - but I wouldn't count on it given past behavior of being reluctant to put out negative data. In any case the data reveals coming out of the hold should provide more calibration.

Things I'll be looking for:

a) reversibility?

b) other liver function tests besides alk phos and unconjugated bilirubin (compared to ALT and bilirubin the alk phos and conj bil is much milder concern - but if there were even low levels of the ALT and bili elevation ... watch out)

c) trends in all tests over time. The PV/ET liver data clearly had 'trends' when last reported (1st Q last year - any updates since?) since it only popped up after long dosing. Have values trended worse in the intervening time? When were the trends visible (as steadily increasing over time - vs pop)?

d) suspension of MF and more serious diseases? So far only PV/ET (chronic conditions) have been suspended. I think there is some chance it remains isolated to PV/ET if(!!) all of a thru c above look good.

Note that this will provide good clarification of both the company's behavior and the FDA's sensitivity to liver issues.