RE:RE:RE:RE:RE:RE:AA ?
We need to get panc or Anal into a phase 3 trial asap and hopefully an adaptive trial where they can have a look and then possibly grant AA as a result. Because the patient numbers are so low in both the panc and SCAA it is unlikely at this time that AA would be granted but maybe the FDA would look at the overall picture of the Panc and SCAA and can see that it is showing efficacy and you just never know what they may say. On that note we do not even know if onc has applied for AA and one would have thought that they would have done something like that when the original results had been released some months ago at which time we should have had an answer by now.
From the SCAA trial
Patients in the SCCA cohort, presented at IMACC 2023, are undergoing second-line (2L) or later treatment with a combination of pelareorep and atezolizumab. Ten patients are to be enrolled in the first stage of the study, 8 patients were evaluable based on an October 23, 2023 data cut-off date. Two or more responses out of the first ten enrolled patients are required to satisfy the Simon two-stage success criteria.
They only had 8 evaluable patients and I cannot find a trial that has been approved for AA on such low numbers so onc needs to hurry and either continue on with the SCAA enrollment to get the numbers up where AA could possibly be granted or Is it possible they could go straight to a phase 3, This I do not know but they have had a lot of succes with pela and Atizulamab so one would think Roche would seriously be considering either a partnership or BO and if indeed they have been negotiating since panc results came out and then with the SCAA update, the answer should not be too far off IMO only.