Ann: FDA Fast Track Designation Granted for VAXINIA Trial Program, page-87

Last night I wrote,

Some posters have discussed Orphan Drug Status as a prospective designation for Vaxinia. I'm not sure that is a pathway to consider as opposed to a Fast Track Approval via the Significant Breakthrough Therapy route, when looking into their treatment of bile duct cancer

This morning when I awoke I took a closer look at some of the drugs that have obtained orphan drug status in Phase 1.

Q. What have these drugs got that Imugene doesn’t have? I thought to myself.

1. Two hours later I had the answer, from a subsequent IMU ASX announcement.
   The answer was nothing. They have nothing on Vaxinia

I am so happy for YF and all involved. This is phenomenal beyond all belief for those who have continued to believe. And as suggested, it is surely the beginning of many fast track designations for this incredible drug, aimed at treating ALL CANCERS. Higher doses here we come…

Credit to LC for continuing to cultivate a close working relationship with the FDA. Firstly the FDA IND for Oncarlytics, now this exceptional if not extraordinary result. December 2023 is delivering the climax many of us had longed for…Everyone prays for a fast track designation from the FDA, to kick into revenue sooner rather than later, and NOW WE HAVE IT!

IMO Surely now it's a certainty Vaxinia is going to one day be in the arms of patients the world over…..Hallelujah

My only sadness from a selfish point of view is the stock probably won’t reach my $1 target in 2023. But now over time its a definite, it’s simply a matter of time. We shall all catch up in Noosa. Its now but a question of when…

How good. Surfing, fishing, sailing, golfing, or maybe just drinking. Take your pick. Noosa here we come...I really can't contain my excitement. Who cares? iI this isn't a time to go over the top, what is....

Enjoy your day...

Opinions only



When dreams become a reality