| As I recall, while the basket study may have paused with TNBC, it always stayed "active" on the clinical trials website. Generally, when a trial gets changed to "active, not recruiting", it means that they are continuing to treat and follow the patients they have already accrued, but will not be recruiting further patients to the study. Generally, a trial will not go back to "active" once it's changed to "active, not recruiting". That's why I find this so confusing. To my mind, the cost of initiating new P2 trials when you had a perfectly good one running makes no sense. The two stage approach, assuming that is the plan, could easily have been done within the basket trial without added cost. So, again, as best I can tell, either they've already accrued enough to satisfy AA requirements, or, they aren't planning on applying for AA, and moving forward with a P3 in the standard way. I suppose another alternative is that they are setting up a P2/P3 study, where they finish off the P2 numbers they need for AA, then move straight into accrual for the confirmatory P3 while the application for AA is going through the FDA process. So, using TNBC for example. The initial basket study numbers to get BTD were, I believe around 58. If the company had gone the P2/P3 combo study route, they could have accrued the additional 42 patients requested by the FDA, and then zoomed straight into the P3 while AA was pending. Of course, the risk here is that if the 42 patients hadn't supported AA, you're on the hook for a P3 study, and have to eat the costs involved with shutting that down, or continuing it without moving forward with the AA application. Hopefully the company will offer some clarity in 36 days. |
