If the HR value at the end of the trial remains at .75 or better, won't the P value fall right in line with what's required.
While I believe the HR value will improve, it already put TNFerade in a position that's better than many other recently approved drugs and all that have been approved for Pancreatic Cancer.
I believe there's a Secondary Endpoint that hasn't been addressed that by itself could lead to approval. I'm talking about the percentage of resections in the TNFerade group when compared with the SOC. I've attended a couple Pancreatic Cancer Symposiums where speakers were investigators for the PACT Trial, they were clearly enthusiastic about how many patients on TNFerade were being resected. In one case, Dr. Farrell reported that 5 of 11 had been resected, and others had shrinkage of their tumors which would have permitted it, but mets were found eliminating the possibility.
It's clear that handling Mets is the key to curing substantial numbers of pancreatic cancer patients, there is another trial with another experimental drug in combination with TNFerade that's being tried in patients with mets, it will be interesting to see if they're making any headway.
Gary
