Why IMU is a multi multi bagger, page-22784

@Taureanbull "The Cholangio expanded trial is Vaxinia. If it confirms earlier MAST results it will move into a Registrational Trial."

In one of the investor videos, I heard LC say they will move it into a confirmation trial if the same results continue but I wasn't exactly sure what she meant. A confirmation/confirmatory trial is run when a drug is given Accelerated Approval (the FDA now prefer these to be commenced prior to Accelerated Approval being granted; to ensure the trials are run and completed in a timely manner.) so, I thought that may have been a slip, and she was using a term they had used in the boardroom rather than the vague language that is usually used. However, I'm sure I later heard her, in a subsequent video perhaps, say they would push it into a confirmation trial like they are currently doing with Azer-cel. I'm pretty sure LC has previously used the terms pivotal and/or registrational so, I certainly noticed the change in the term she used. And I understand the plan for Azer-cel is to run this next trial then run a registrational trial. So, I wasn't 100% certain what the plan was (unless what isn't being said is that they are planning to run confirmatory trials with a submission to be made for accelerated approval once the trials have commenced. If granted, then great and if not then the see out the trial and assess what to do from there). It's obviously difficult to provide solid confirmation on the plan if the plan requires FDA guidance before being finalised, so I make no criticism on the uncertainty that currently exists as we will find out once the time is right.

I had confirmation (via a question I asked in one of the webinars last year) that the plan for onCARlytics remained the same as the initial plan, which was a quick Phase 1 followed by a Registrational Trial if the phase 1 data looked promising and supported that path. So, unless there are any hiccups, I'm expecting a registrational trial to commence early next year... but we do need to see how the onCARlytics/blinatumomab cohorts fair before we'll know if that remains the plan (p.s. the combo cohorts are yet to commence despite being announced more than a month ago, so not sure if there will be a delay).

So, IMU may well have three drugs running in pivotal/registrational/confirmatory or whatever term gets used next trial next year. I'm looking towards FDA registrations rather licencing deals for what might be my end point, so I think the end of 2025/early 2026 is reasonable if any/all three of those drugs have quick success. Hopefully there will be positive price inflection points long before then.