But, with a 69% objective response rate really we felt that we had demonstrated a very, very strong signal. And what we wanted to do is move it into a more stringent environment. So what we’re talking with corporate partners like is randomized Phase 2 in the 60 patient range. We’re also speaking with cooperative groups that would actually be capable of running a Phase 2b/3 program. So an adaptive design where we would enroll, I think, it’s 60 to 80 patients in that Phase 2b program. And if we’re seeing the signal that we want to see, we would just seamlessly move into the Phase 3. This is very attractive because the cooperative groups provide a lot of expertise and cost deferral, but more importantly, they are expeditious. They have a pre-approved protocols with the FDA.
So if we can get through their selection process, it’s just a plug and play to get into the Phase 3 environment. Sorry Patrick, I’m trying to recall, what was the first part of your question?
Patrick Trucchio: Yes, just on the on the registrational pathway for HR-positive/HER2-negative with Pela and with this BRACELET-1 data, just want to clarify that you would only need the one pivotal study going forward for potential submission for – the regulatory submission for approval. I just want to make sure that that is what is possible. And to the extent that it depends on the ASCO data, how does – just how does that facilitate this accelerated pathway?
Thomas Heineman: Well, absolutely. That’s also another great question. IND.213 showed that doubling of overall survival, we took that to the agency and what they told us is this will provide you with a special protocol assessment. For anyone who is listening, what that means is we’ve agreed to a protocol with the agency and they have already, because they have granted that the IND.213 de facto is one of the two required randomized studies. So, we are only one randomized study away. Now people ask me like, they are like, why would you then go and do BRACELET? And really the question for that was IND.213, we were working under the assumption that this was largely lytic. The result very strongly indicated that lysis was probably occurring, but the mechanism driving this was really a T-cell-mediated response.
So the agency said, listen, you can start that Phase 3, but you’re doing so at some tremendous risk. If you don’t fully understand mechanisms of action, and if you don’t have at least some biomarker planned that measures a T-cell response that would tell you whether or not those patients are responding. So Pfizer was looking at the end of Phase 2 minutes and the SPA and they agreed, they said, listen one of the things that we can actually look at that we’re quite excited about, IND.213 was a very heavily, pre-treated patient population. Just to remind everyone, we saw about a three-week improvement medium PFS. But in that patient population, everyone had already been exposed to or had failed a taxane. Where BRACELET is a little bit different is it recapitulates what we saw in IND.213, but it does it in the group of women who are taxane-naïve.
