ImetelChat

He qoted Irish saying(paraphrased) that she had learned that cancer cures or near cures don’t come easy when there are competing interests. It seems that I am not the only one that thought the fda hold was fraudulent and desugned to give Incy and Celg some time. Why has there not been more made of this?

Nuts, I am not one for conspiracy theories, but whatever happened it is unlikely the FDA will withstand the weight of Janssen as opposed to the days when Geron was going it alone. When the curious hold happened it was a "partial" hold not a "complete" hold so some patients continued to receive therapy, unless one showed CR or PR therapy was stopped thus excluding those with CI. Some of the fault may have been Geron's we just don't know, as the Geron safety monitors included a panel of distinguished hepatologists. Apparently this was not enough for the FDA at that time despite prior clinical experience with multiple solid tumor studies not to mention the myeloma, CLL study and the thrombocytosis/PV study. (It was implied that there was a record keeping and patient follow up problem.) Of course that was many years ago and we have a "new and improved FDA" with the avowed mission to simplify and shorten the onerous approval process. I do think Geron has all the makings to be a test case for the actualization of this mission statement. We will know soon... bp

BP I hope you are right in guessing the weight of Janssen vs. Geron. My suspicions at the time were based on the LFT elevations being so meaningless in the oncology world that Geron admitted they did not think them relavent to include in their initial reports. I hope whoever pulled the leverat the time is no longer with the FDA or sold his CELG and INCY holdings!

What is sad is the lives that were most likely shortened by being removed from the study at the time in light of the implied MOS and stable disease Imbark is demonstrating.

Nuts