The CF33, Vaxinia and Oncarlytics Deal, page-732

Hi @davybabyk and @Outlander2

I hope you gentlemen don't mind me tagging you both.

I'm trying to calculate some timelines regarding a potential FDA approval for Vaccinia and would love to have you confirm or question my thinking. To provide context I have zero science knowledge.

I'm looking at the MAST trial and we know that the team have moved through the cohorts seamlessly, and even though IV started after IT it has now progressed faster so that's brilliant news IMO. For the sake of this exercise, I'm focusing on the IV as a monotherapy only.

Let's hope/assume that cohort 4 is the optimal dose. If it is, then am I right in also assuming that even though our trial patients have failed two previous lines of treatment and by all reports would be both desperate and very sick, that Vaccinia would show results within 30 days? My understanding is that it basically has one job, to find, infect and replicate in cancer cells and only cancer cells and that it does this job very well. If it's at the optimal dose then it should either work quickly or not at all? Is that correct?

Let's say we have 10 patients in this cohort and by all reports they are lining up for this trial. (I would be camped at the front if it was me or a loved one). How long after dosing are we looking at before the data is relevant? Can we say 30 days for dosing and then 30 days to analyze the data or is that unrealistic?

The team already have significant data so this would just be more relevant data at the optimal dose. I assume the data has to be independently verified and audited so we can add another 30 days for that.

Therefore, my thinking is that an FDA Fast Track application could be lodged within 90 days from say July 1st to pick a date. We know the FDA will make a decision withing 60 days so therefore is it at all in the realms of possibility to think that we could have an FDA approval at the end of this year? Obviously assuming Vaccinia works and is safe of course.

Am I in the ballpark here or being overly optimistic?

Thanks in advance to anyone with scientific trial knowledge here?