Yes and no. Have they biopsied? Most likely yes as that is likely the only way to validate CD19 expression.
Would it have to be reported by Imugene to the ASX? Eventually, yes. Before they can move into the combo? No.
To report the data will require an FDA representative to undertake an official cut, and based on guidance from IMU, we don’t expect that to occur until later in the year.
You’re seriously underestimating the ethics rigour applied to clinical trials by the hospitals and doctors that run them if you think it would be allowed that patients with solid tumours to be treated with Blincyto if there wasn’t some evidence to demonstrate onCARlytics was doing what it needed to by causing CD19 expression on solid tumours. Put simply, it would be unethical to administer Blincyto to solid tumour patients without knowing the first part of the equation was highly likely occurring. They may not validate it in patients between treatment with onCARlytics and Blincyto but seeing it occur in monotherapy patients would be enough of a validation.
But you are right, we as shareholders don’t have confirmation but we don’t need it at this stage. The doctors running the clinical trial however, they would almost certainly need it and they would have seen enough to form their own opinion that conditions are right to progress the trial into the combo stage.
It’s no skin off my nose if you want to believe they have not sought to confirm onCARlytics is causing CD19 expression and if you really do believe that, I would appreciate you explaining why you think the clinical trials hospitals and doctors would allow the trial to progress to the combo stage without some confirmation?
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