I too focused on that paragraph. And the same section you did about the CRC trial.
..." as well as do some redesign of our colorectal cancer, updating it with the information we have about PDL-1 and the role of using checkpoint inhibitors in this case in patients with colorectal cancer who started with cold cancers
And first thought. He is going to ask to include the ICI before the trial ends. Because these need to be administered in the appropriate time frame ( whatever that is ). And he had made a hint of the FDA being amenable to some changes to the current trial in a past talk.
But the more I thought about it, I also paid attn to the TNBC line.
"And that will give us the opportunity both to submit our proposed follow-up study in triple negative breast cancer, submit a compassionate use program in triple negative breast cancer"
I know in order to get accelerated approval, there has to be a coming trial thats teed up and getting ready to go
And Im starting to think if the meeting encompasses both trials/subjects.
He is going to request that they tie all this data together from this current trial and make the TNBC a confirmatory trial.
I dont know if the timelines for getting sufficient data before TNBC etc work out. Or even if its likely possible.
But I bet its on his mind.
..." as well as do some redesign of our colorectal cancer, updating it with the information we have about PDL-1 and the role of using checkpoint inhibitors in this case in patients with colorectal cancer who started with cold cancers
And first thought. He is going to ask to include the ICI before the trial ends. Because these need to be administered in the appropriate time frame ( whatever that is ). And he had made a hint of the FDA being amenable to some changes to the current trial in a past talk.
But the more I thought about it, I also paid attn to the TNBC line.
"And that will give us the opportunity both to submit our proposed follow-up study in triple negative breast cancer, submit a compassionate use program in triple negative breast cancer"
I know in order to get accelerated approval, there has to be a coming trial thats teed up and getting ready to go
And Im starting to think if the meeting encompasses both trials/subjects.
He is going to request that they tie all this data together from this current trial and make the TNBC a confirmatory trial.
I dont know if the timelines for getting sufficient data before TNBC etc work out. Or even if its likely possible.
But I bet its on his mind.
5
