RE:RE:RE:RE:RE:RE:RE:Fast track designation I think the surprise here is the timing, I think you might expect them to get it at some point, just not predict it would be this early. But they knew some decision yes/no was on the horizon because they applied for this 60 days ago. Maybe it's bringing into the basket trial very difficult to treat cancers like pancreatic is what swung it.
scarlet1967 wrote: "That is certainly a strong endorsement of the MOA, and recognition of superior chances from using well known cytotoxic attachments, IMO."
This my take too as mentioned earlier the agency seems to link the fast track designation with unmet medical needs which per se needs to show a decent MOA.
Spartrap wrote: That is certainly a strong endorsement of the MOA, and recognition of superior chances from using well known cytotoxic attachments, IMO. Essa Pharma (EPIX), another canadian bio, got it just at the begining of their mCRPC Phase 1, back in September, but for a compound that is essentially an ameliorated version of a compound that failed a previous P1 for having bad PK/PD. BTW, EPIX is now valued ~US$600M, for a single compound with no human data yet, as the P1 is still running...
Wino115 wrote: My 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.