RE:RE:RE:RE:RE:RE:News out on Goblet trial with Merck My guess is eveything is locked down under gag orders, due to signed confidentiality agreements with the big guys.
But let's not forget that we have a completed Phase II trail with a note from the FDA stating the FDA is in favour of the Phase III trail. The FDA was so impressed with the results of the Phase II trial that they stated that they would reduce the Phase III trial from 850 down to 450 patients. Then the FDA stated that there appears to be a biomorker in the data that was not officially captured so FDA recommended a side trial to determine, well actually properly-officially capture the data on the biomarker. Thus the AWARE-1 and ONC confirmed 2 biomarkers through that trial.
The FDA also noted that if the biomarkers actually exist they would look at reducing the Phase III trial down to something like 225 patients due to afficacy using the biomarker(s).
ONC also stayed in the past that the FDA has been allowing a new kind of trial set up where ONC can make adjustments to their trials along the way without starting over. This process is new and other company's trails are starting to run the same way.
What is the importance of that ?
ONC has stated that due to this ability to change the trials somewhat through the process means that they do not need to finish the side trails BRACELET -1 or IRENE to start the Phase III trial.
So ONC can use initial existing data to define the parameters of the Phase III trial and adjust the trail as more data comes in from the Side trails.
As I noted in a previous post in this thread, I recall ONC stating that they anticipated starting the Phase III trial in mid 2022 cause they needed some data from the side trials, but could start before the side trails were completed.
Would be nice of ONC to firm that all up now, as we are getting close.
ONC is worth a lot more than 2-3B$
Time will tell.