Biotech Values

[iandy]

I haven't found any explanation on 3 liver failure cases. Were you aware of these cases before FDA label? I don't think at this point you can exlude the possibility that ponatinib better efficacy but with higher hepatotoxicity. We have to wait and see once it is used in wider patient population.

Discontinuation due to liver toxicity was not a feature of the PACE trial.
All 3 serious events were in patients at the extreme of the patient population.
They believe liver toxicity will be inconsequential in the use of the drug.

Pona has been granted the European version of accelerated approval.
There will be no black box.

We will see if they give the drug the broad label granted by the FDA.
While the European agencies have been generally tougher on approvals and reimbursements than here, I think they are keenly aware of the superior efficacy of this drug.

I want to thank you for your input.
I am always reevaluating my investments.