Could the EAP Be Giving SELLAS More Insight Than We Realize?
One thing I don't think enough people are talking about is the Expanded Access Program (EAP).
We all know the REGAL Phase 3 trial is blinded, so SELLAS can't see who's receiving GPS versus control or how the trial is ultimately performing until it's unblinded.
But the EAP is different. Patients receiving GPS through Expanded Access are outside the blinded REGAL trial. That means safety and patient outcomes from those EAP cases can still be observed and collected.
Obviously, EAP data doesn't prove Phase 3 success—there's no randomized control group—but it can give physicians and the company additional real-world experience with GPS while REGAL continues.
The fact that doctors are requesting access to GPS for eligible patients, combined with the encouraging earlier-phase data and the continued delay in reaching the 80th event, is what keeps me interested.
Question for everyone: If you were management and you were seeing encouraging real-world experiences through the EAP (without being able to see the blinded REGAL data), how much confidence would that give you heading into the final readout?
