[chrisy]

Hi Eric,

My experience with this trial is that the protocol is very strict, because as Jackie says they need to have a valid study, and because it is truly an investigational drug so they really need to be cautious. However the protocol is ALSO quite complicated. And there is some wiggle room sometimes where there are gray areas.

I think the key is to get the clearest understanding of 2 things:

1. What exactly does the protocol say about being discontinued from the trial due to progression? Is it progression of a certain "%" size and what is that. And how does Caryn's CAT scan result fit into that.

2. Is this drug working or not? You may have a valid question on whether this represents progression while ON the DM1 or progression due to NOT getting it. Can you get clarification from your doctor on this point - is the progression an indicator that the DM1 WAS working (see how it grew when she wasn't on it??) or that it WAS NOT working (see how it grew even when she got the DM1???). If you can reasonably say that Caryn was getting clinical benefit, that is where there may be some wiggle room for continuing, if her doctor supports this.

As Caryn has had significant adverse side effects throughout, and now possibly evidence of progression while on treatment, you may not be able to successfully argue for keeping her on the trial. On the other hand, if both of these things are the reality, perhaps this drug is not the right option for her despite all our hopes.

Remember, although Genentech certainly wants to have a valid trial and of course hopes the trial is "successful" in terms of demonstrating the safety and efficacy of the drug - they also (I believe this very strongly) want to do what's best for the patient. As does Caryn's doctor.

My thoughts are with you, praying for the right decisions to be made by all.

Much love
Chris