Mike Kearney
That is correct, Andrew. Care to Live is a not-for-profit corporation. It came into existence as a patient advocate group. We helped support the Provenge Now rally in Chicago and the rally in Washington D.C., and then we helped place an ad in the Washington Post pertaining to this advisory committee vote that you said. It was voted safe, and it was voted effective. The vote was 17-0 safe and 13-4 that they said it had substantial evidence that it works. Well, now Care to Live has turned to litigation as the only remaining alternative. Care to Live hopes to get safe and effective immunotherapy to patients who have no other options, and we want to get it to them now. This is an emergency.
Andrew Schorr:
Well, it is certainly an emergency if somebody has more advanced prostate cancer and there are experts who say, you know this cancer vaccine could help you in your case, but too bad, the FDA has delayed it, and the delay could be, what, many month? A year? Several years?
Mike Kearney
We've heard anywhere from halfway through next year to the end of next year. It could go all the way out to 2010.
Andrew Schorr:
Right.
Mike Kearney
These gentleman, they just don't have that time. Someone dies every day of prostate cancer, so we're seeking an emergency temporary and permanent injunctive order from the court as well as declaratory judgment that the FDA did arbitrarily and capriciously deny dying and terminally ill patients access to a safe immunotherapy.
Andrew Schorr:
Now, you've been talking with some other organizations too, and I bet you have gotten the sense that this has happened other times too.
Mike Kearney
It seems like it's happened a lot recently. I think Mike Huckman of CNBC just had a program on where he talked about 55% of the drugs are being delayed like this compared to last year at this time. So, 55% of them the FDA is keeping, and there are some good immunotherapies. There is one for the bone cancer for the children, and we have some doctors who are just astounded that this stuff is not being given to the people who are in such dire need.