RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:Using the ATM or
westcoast1000 wrote: Thanks for the encouraging post while the stock is down after great news.
ksw has stated things very well here, with the memories going back to the dog days, and through to the history post 2016 up to today.
I have always wondered what we needed to do to verify the biomarkers. That is a tricky question in terms of hypothesis testing, or so it seems.
if you look back through NRs after they were well into AWARE-1, when ONC announced the GOBLET, in the NR, ONC kind of slipped the beans on the biomarkers stating, they wanted to see if the same potential biomarkers that they noted for mBC existed for Gastro.
The FDA would not have allowed the GOBLET trial if the resutls in other indications were poor. And Roche would not be spending time and money on a trial if other results were poor.
So IMHO they spilled the beans if you read between the lines.
AND... Gastro had a response from every patient. IMHO that means they ran blood screens for the biomarkers and selected patients accordingly. How else can you explain a response from every patient. That in itself is pretty much unheard of for cancer.
IMHO the biomarkers are confirmed. We just need to see that in and NR!
And that data should come out within the next 6 weeks with the final date of the AWARE-1
So at that point in time, after AWARE-1 NR release, the only thing left to do, at the request of the FDA and/or BP is the release of BRACELET-1 data...
and then apply for Phase III registration.
But I think GOBLET will speed the timing up on all of that. How much ???????
As per the other thread, if its 90 days for GAstro Phase III application and 30 days for FDA approval, we might be 120 days minimum from a Phase III Gastro approval. So March 2023 maybe.
I can wait...
Cheers!