There have been several posts made about timeline slippage in...

There have been several posts made about timeline slippage in the Azer-Cel trial. And yes a first glance that is probably correct.

However, it’s interesting to note that this trial has been modified mid trial to include Cohort B. The CEO must have hotline to the FDA to change the trial protocols and still deliver these results in exactly one year from taking possession of the drug.

Some comments also queried the increase in Trial Sites. In my view the increase to 15 trial sites including 5 in Australia , does 2 things . Because it takes time we to enlist trial sites it set us up for a rapid Registrational Ph2/3 trial. It also adds weight to a positive outcome if the results can be replicated across 15 sites and 2 countries.

LC’s comments that the data from Cohort B will be included in the registrational trial tells us that effectively this trial is well and truly underway . And it’s got 15 sites actively recruiting. The Drug Delivery or combo has been optimised.

IMU can’t call it a registration trial until they get FDA tick off approval. But we know it’s full steam ahead. So maybe we haven’t lost any time, but we have definitely boosted efficacy and reduced toxicity. A big round of applause for the Team Imugene is warranted.

So the next question is , have the pre-clinical animal trials for ONCARLYTICS/Azer-Cel combo been modified to use IL2 to help the T Cells?

I’d bet that triple combination is being trialled in mice! So we now await the announcement for the PH1B trial of our own two products Oncarlytics and Azer-Cel in humans. That won’t be far away,

The minute they decided to use IL2 in THE DLBCL trial, they would have started on the mice.

It’s fairly obvious a cap raise will be needed BUT this time it will ba major US institutions. Thats why PH did the recent video to explain he is well integrated in the US Biotech Ecosystem.

IMU know exactly when the next Oncarlytics Announcements are to be released and when and where the capital is coming from. In fact this has probably already reached advanced stage of negotiations. That is if a deal for Azer-Cel is not inked in before then.

Monal Shah would be flat out fielding calls all week regarding the Azer-Cel results .