Replies to post #85791 on Biotech Values

[iwfal]

ZGEN - Just listened to the Oppy cc and regarding the possibility that they overdosed:

a) Ramos stated that they 'believe' that overdosing was happening based on some of the pharmacokinetic measurements (implying that they don't actually know for certain from records).

b) Ramos stated that this could happen because they originally shipped with a different, much more concentrated, dose anticipating a significantly higher MTD. (I think it is probable even the 3.0's were OD'd. Assuming as fact that the 1.5's were OD'd and given the EASL poster it is a virtual certainty that the 3.0's were also OD'd.)

c) Ramos stated that they went out and re-educated the trial sites on the exact steps needed to dilute properly. And the last 22 patients were treated after this re-education. (Looking at the slides the 22 patient mark is PRECISELY aligned with the patients not yet enrolled at the time of the EASL conference. So my guess is that in preparing the EASL paper they noticed the pharmacokinetics.) Regardless it means that all the 2.25 in relapsers was with a good dose as well as the 1.5 with the naive. And they are the ones that show RVR.

PS She/they answered 2 of my questions about the ph ii - one of the key purposes of the dosing part of the trial is to understand SAE after 4 weeks. And the slides show that the randomized portion doesn't start until after EVR is analyzed.

PPS If they have pharmacokinetic data AFTER the re-education I think that would pretty conclusively prove that they overdosed the earlier patients. It would be nice to know if they have looked at that.