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volgoat

09/05/15 10:37 AM

#233673 RE: hayward #233672

1st look in is/was a non event, just safety related, 2nd look in around Oct/Nov is when it can be stopped.

The pps does not mean anything until then, we know it's safe and lots of secrets in pphm land, such as Abvie, MSK,AZ that nobody knew anything about and 20+ other ones we haven't heard about.

There is a reason for avid being ready and the mass hiring the last year and a reason and a reason MSK and AZ are on board, they know the data


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Protector

09/07/15 8:23 AM

#233820 RE: hayward #233672

hayward, I think such look-in would be communicated by the IDMC by letter to the CEO or possibly to Shan and/or Garnick, but for sure only a single person inside PPHM. I think in a close circle (if there is no need to involve other people because the IDMC advice would be something simple as CONTINUE) those people COULD keep that between a few of them.

If of course this needs to be discussed in a meeting with several employees and other people that are needed to react to the letter etc then of course what you are saying increases in chances.

However, how many knew Memorial Sloan Kettering was coming? How many knew AstraZeneca was coming ?

And for MSK I don't know, but for AZ I am sure the collaboration agreement, since it includes a clinical trial, was certainly not something above mentioned people wrote on the side of their desk while eating their daily fruits. It will have involved legal, research, etc...

So if that didn't really leak then I think a First Look-in might have been kept secret too. However, being late 9 weeks now on my simulation, I do believe we didn't have it yet. For me to be right retroactively would be great if we learned that it took place already 8 weeks ago :) But that is wishful dreaming on my behalf :)

I think golfho's prediction will be closer and also that for this ECOG group 7 and 12 for the eventing of ctrl and bavi arms may have been on the low side. We've seen control arms ranging between 3.4 over our 5.6 till over 7 but I am not sure these where all the same ECOG's as in our 2nd ln NSCLC PII.