They need the partnership, as well as the manufacturing capability, before approval is possible. The FDA may indicate a position on a drug, but won't approve without an approved manufacturing sourse as I understand it. Either company could be a suitable partner, but there are many others as well.
I'm just finishing a bout with cancer myself. First I was found to have sebaceous carcinoma in growths that have been on my nose over 40 years, had the Dr not agreed with my wife that it was a little reddened after a three weeks cruise, he'd never have sampled it. It was cured with MOHS surgery, but led to a C-T Scan with full contrast. I'm told without the contrast they'd have not detected a mass in the kidney, but today I'm returning home from the removal of the mass, but saving of the kidney. It's been almost a week since surgery and the Drs that judge such things still aren't positive, but currently the experts are leaning toward it being a weak renal carcinoma, rather then completely benign, which they originally thought.
I'm learning we're not involved with something that precise in Cancer, opinions of experts often go in very different directions. I suspect that some patients entering the PACT Trial probably shouldn't have gotten in, but if the right Drs. indicate they haven't, or can't, find Mets, they're eligible.
The problem is, just a few people added to a trial that are improperly identified can really skew the data. Dr. Farrell at the Pancreatic Cancer Symposium made it clear that tumors had shrunk sufficient in additional patients, but mets were found, so those patients couldn't be resected. Still 5 of 11 patients resected is very impressive data, and that's what he reported.
Gary |
