what could go wrong?, page-50

Supertramp here, from my planet....

;-)

When I read neo's post about how can the phase 3 result be so different to the phase 2 I knew it was because the trial was different (different combinations, and the KRAS stuff (which I didn't go into)).

I have been expecting a better result to our control in the phase 3 trial compared to the phase 2.

Hence, to respond to neo's post I wanted to find a link to that difference, and eventually thought I found it back in the afore mentioned pdf from Feb 2008.

ok, that's my excuse out of the way.

But as you can see there are differences between our phase 2 and our phase 3 trial.

As for the 13 months, I stand by that. I know that on the surface it might sound too good to be true, but that's what the evidence is saying.

The fact is that we know there are at least 66 people still on the trial. Statistically few of those remaining will be on the control arm (we know that from historical data). We also know how long people have been on the trial, and we can calculate an average start date (not that we need to do that).

There must be some of you out there who are putting your data in excel. What is your modelling telling you? I can only get the HA arm below 10 months by cheating the figures. 13 months is minimum that I get atm with a high probability.

The 13 months claim is coming from the figures, not from wishful thinking.

As we know, acl were expecting data lock about 8 months ago.

So what figures are you getting?

There are plenty telling me that I can't be right, but who can produce a realistic figure (based on the data that we have) that can suggest something different!

There has been the odd "dodgy Eastern European clinical trial sites" claims on HC. But it's the same as used for Abraxis's drug. They are used lots and are accepted by the fda.

Cheers
ps. a great thread going here, thanks to all contributors.