RE:RE:RE:RE:Fast track designationMy hunch, and it would be nice for THTX to clarify this if so, is that getting it prior to any trial whatsoever shows they understand from the pre-clinical data presented that it "appears" to be more on the safe side of drugs and "appears" to have a good shot at efficacy. Hence, get moving boys and we'll help your process through the regulatory issues faster. If that is the case, THTX really should talk about what they believe the FDA saw in the application and what they said about it. More than just one sentance saying... "...this is good..."
Wino115 wrote: Very unscientific, quick look shows Fast Track doesn't happen that much before some kind of trial. This tiny sample shows a few post Phase 1 safety and dosage but more around Phase 3. On Sutro, I see they used to reference fast track in the presentation but took it out. I wonder if the Neutropenia they show in a lot of the patients made the FDA want more data and scrutiny of the drug. Just a guess.
| SeaGen SGN-35 | In Pivotal Trial with 100 patients |
| RhoVac Prostate RV001 | Phase 2 trial, 175 patients |
| Immunogen Mirvetuximab Ovarian ADC | Phase 3 Trial |
| Steba ImPACT Urothelial | Phase 3 Trial |
| Rafael Pharma CPI-613 pancreatic | Phase 3 |
| Immuonedics Trodelvy (blockbuster) | Phase 3 |
| Ambrx ARX788 HER2 Breast | Phase 2 |
jeffm34 wrote: Fast tracking a drug is mainly about the indication and not about the prospects any particular drug might have.