I believe we're in a period in which a ROW partnership could occur at any time for IMGN853. Why? Because the company has clearly indicated the intention of speaking with European authorities about the compelling data they got in the Phase 3 Trial for those patients having the higher levels of platinum resistance. Clearly the FDA wants another Phase 3 Trial, but Europe or other countries may be more open to being flexible, and in that IMGN has stated they wanted a ROW partnership, the time would be right to get one, or more. It would also make far more sense for a BP with a substantial presents in Europe to discuss approval, rather than IMGN who has never done it before.
I'm just back from another hospital stay, it was supposed to be a simple operation to remove a part of a disk that was impinging on a nerve in my back, I was supposed to go home the next day. Nothing is simple for me, I came out of surgery with intense groin pain, it was the Memorial Day weekend, so things didn't happen quickly, but a previously undiagnosed hernia was found to be causing the pain, and I had surgery for it late in the week. I'm on the mend, but still on pain meds as it's somewhat better, but still pretty intense.
While what was done was totally unrelated to City of Hope, my Dr. there was still consulted on the drugs which they were giving me, so they remained involved.
Gary |
