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iwfal

03/19/13 10:10 PM

#158557 RE: biopearl #158533

GERN -

Who says they dropped PV? They just stated they had enough data to stop the study. This may not mean the 2 PV patients are not continuing to receive therapy.



1) No one planning to continue forward in an indication stops at 2 patients - and PV and ET are very clearly different diseases.

2) When they stated they had enough data they were clearly talking about ET - since they said they had enough data to validate the data that they reported at ASH (which was ET specific).

3) The fact that the patients continue to get therapy does imply that have been no catastrophic SAE - but I never said they did. Only that that artifact, of coincident phosphotase and bilirubin, in chronic dosing definitely warrants reporting because it will likely get regulatory attention - and they didn't report it at ASH.

I think the liquid tumor data is remarkable for ET, especially as it pertains to effects on precursor cells, hope it has just been seen through the (dirty) lens of the breast and lung studies so far.



Yes, I agree that the hematological AE in the solid tumor trials does seem to indicate benefit in the hematological parameters not reported in ASH - i.e. if they carried forward as treatment artifacts in PV it would be good.

Regardless, my concern with Geron is that they appear to generally hide (i.e. leave out) their data-that-doesn't-look-so-good. Second concern is that they are moving like snails. Third concern is that they may actually have a chronic dosing problem - removing ET and PV from the possible treatment indications. Fourth concern is that even if they can dose in PV it may not have proper efficacy since the ONLY efficacy data they reported for ET was the ET-specific data (vs, for instance, spleen size, which is important in ET, albeit more so in PV).