Great announcement and confirmation of positive progress so...

Great announcement and confirmation of positive progress so far.

The path to an FDA approval for a registrational phase 2/3 trial is crystal clear and direct as confirmed by Paul Woodard in the video call in early September.

We need 30% to 50% complete response rate from 10 to 20 patients with 6 months durability. The durability is key here. If the complete response doesn't last at least 6 months it doesn't count from an FDA approval perspective.

From the 7 patients so far, we've got 4 CR's 2 SD's and 1 progression. We know at least 1 of the CR's has gone for 10 months so that's one in the bag. We need 2 more of the CR's to click over 6 months and we're looking good for a registrational trial. The language from LC and Paul yesterday in the interview was very encouraging and the announcement states:
"Ongoing durability (length of time without disease) update to follow as the data matures – longest durability ongoing at 10 months."

Let's hope we can get two more over the line in the next few months and wouldn't it be fantastic get it to 50% 6 months CR's from at least 10 patients by June.

If we can get our first approval in this space of huge unmet need we can then hopefully find a partner to help us get this to market and then continue trials to go head to head with Auto CarT's and also into additional blood cancers and in combination with OnCarlytics.

The latest presentation stated that both Fast Track and Orphan Drug Designation are potentially coming this quarter so it would seem that some positive discussions are taking place with the FDA.

Outstanding work from the team at Imugene with this trail so far and best wishes the patients.