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Stephen Hoge

Oct 20, 2026

15:27
So give us just the real quick layman's take of what that news was, what happened.
15:32
Yeah.
15:33
Well, I'll describe it in the context of the phase two trial because the phase three results are coming out and we've pointed that phase two.
15:41
There have been a revolution in melanoma treatment over the last couple decades with these antibodies called PD-1 or immunotherapy.
15:50
People kind of are familiar with them.
15:51
Keytruda is a drug from our partner Merck that does this.
15:54
Melanoma used to be a death sentence.
18:41
I mean, how do you do this? Create an individualized medicine for each and every person?
15:33
Stephen, what does the path forward look like from here on out? I mean, is it that you amend the application to specify that this vaccine would ideally only be for patients 50 to 64 years of age? Do you go back and do you try to run additional trials in older patients against that comparator arm that they want? I mean, it seems like you need to find some sort of way to work with this administration.
15:59
Yeah.
16:00
Again, we we need to sit down and understand what is the specific scientific objection they have to even conducting the review.
16:09
They haven't actually looked at the data file.
16:12
They'd agreed that they would look at it and they agreed that this phase three trial was adequate 18 months ago.
16:17
Our first step is we just we would appreciate a scientific dialogue about the data in the file.
16:23
And, you know, I don't know actually even how to anticipate what what they're asking for.

6 MINS LATER

22:36
What does that show? And do you think that might add any clarity here? I assume it's already in the submission, but.

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