In reply to Jase (reply function hates me or I'm not smart enough to figure it out)
They will see Phase II, I believe the question is whether it will be under the Breakthrough/Fast Track designation or not. I agree with your comments around Phase I doubling as Phase II, although rather than doubling, I feel it'll allow for a seamless transition into Phase II; the sites won't close down or stop treating patients but rather expand and all patients will be at Phase II doses. Which is looking like they will have in the next few months. One thing I am curious about is whether the Phase II will remain as broad across many metastatic cancers or whether it will focus on a few best poised to lead to approval the fastest. They have allowed for a fair few possible outcomes here and designed the trial to be malleable.
The trial design of 100 patients, I believe, was to allow for enough efficacy data to be built within Phase I. The FDA aren't silly, if they see data that is showing safety AND efficacy, they aren't going to say, "Oh let's ignore the CR and PR because this is a Phase I trial only testing safety". The genius is designing the trial in a way to allow for efficacy to also be tested and having it as secondary outcomes. This will allow confirmation and publishing of safety AND efficacy data.
That said, I don't expect we'll see a bunch of CR and PR in the data readouts coming up. Of course, id be happy with this but more so expect CD or PR at this stage, depending on which cohorts make it into the results. It takes months to confirm the data and get it ready to publish, so im not expecting fireworks from the most recent cohorts, although I might be wrong on this. On this basis, we would be seeing data on the very early cohorts, which were at tiny doses. The rub will be to see what has been accomplished at these dosages and to confirm abscopal effect and that the virus is replicating and travelling to distant tumours and replicating there.
Anyway, a lot to look forward to.
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