RE:Fast track designation is big news....where are the pumpers?Aprilstocksgoup wrote: Canada? West? kws? fox
Very exciting !
ONC has FAST TRACK designation in both mBC and now Panc.
FAST TRACK for mBC was designated in around 2016. Then AWARE-1 and BRACELET-1 were added to de-risk the mBC. Which is where the bio-markers were discovered and used in GOBLET.
Biomarkers were used in Panc and thus every paitient responded. Huge!
Lets see what comes out of Dec 7th with AN and the last of AWARE-1.
Next steps... not sure which will come first... Phase II/III Gastro registration by accelerated approval or Roche stepping up to the plate... but in any case... IMHO Panc is now offically ahead of mBC as mBC is hung up by Pfizer's 90 day exclusivity.
The market is taking notice !!!! How can they not now......
Cheers everyone, this has been a long haul, and even closer now....