Registrational Trial Azer-cel - and good early data 4 of 7...

Registrational Trial Azer-cel - and good early data 4 of 7 patients Complete response.

I ponder this trial on a very rare cancer regularly and feel its a mis step by IMU leading to such long and stretched out time frames.
The rare cancer that IMU is treating has a huge and strategic problem.
Rare diseases have small numbers of patients leading to longer times for trials to enrol appropriate patients.
The FDA requires certain numbers of patients to provide a valid and safe reason to accept Azer cel as a registered viable option for patients.
How does the FDA get around this dilemna when you can see Azercel works but without a viable trial number of patients for more prolific cancers like Melanoma.
How many patients tested is acceptable when the available patient pool is so small compared to other cancers who can readily test on thousands of patients in less time?
As the time ticks by and funds are depleted for a small company like IMU I do ponder why pick such a rare cancer to treat?
I know it was the first successful CR but I am not sure if thats financially sound without having a clear picture from the FDA on the concessions they would provide for conducting a trial on such a rare disease.
It may be true IMU have those concessions but if they do I would love to know what the FDA have conceded in the optimim no of trial patients to get this drug to market and approved.
The whole trial and path to market IMHO hinges on the FDA providing IMU with concessions on patient numbers to test to allow it to get to market.
If I knew what concessions FDA have provided or what they need to provide and exactly how many numbers of patients FDA will say is sufficient in the registrational trial to get the drug to market then I will know if we have a shot at getting to market.

We have seen how slow it has been to enrol 7 patients in ten months for azer cel trial Phase 1b. We can do the math once we know number of patients FDA need in registrational trial patients to approve it .
Given 4 from 7 CR is great.
The above would also give us SH a time line to hang on to instead of the statement ' data is coming when its ready'. Not good enough in my view given we shareholders fund IMU and wait patiently.

ONcarlytics
Oncarlytics on the other hand to me holds most merit for solid tumor market and has more chance of making a huge impact on IMU financial success given its broad trial and application to many solid tumours.

I would like IMU to target the largest solid tumor cancer that it has the most success on.

I dont understand how IMU just dont update us more often.
I dont buy the rhetoric that it costs to cut data when IMHO IMU would be reviewing data and results at least weekly in their scientific review meetings and trial progress meetings. I dont accept its a cost issue.
If there is something significant they need to disclose.

Oncarlytics must be close to providing data.

Its not the promise of success that frustrates me. Its the management of IMU who have disregarded myself and others in the process. Despite SH paying their lofty salaries and IMU not having the courtesy or diligence to provide regular feedback and forward looking meaningful timetables of results on trials so we know when the end game is.



This may be a dumb analogy but here goes.
If I go an sit for my drivers license, I know there are certain competencies I much achieve in obtaining it. Vic Roads spells it out and the driving instructor guides you and provides the criteria of what is a competency to achieve a drivers license. You do your test and you either pass or fail based on criteria. You also have option to retest to show your competency.

I see the FDA clearance to get a drug to market similar. Simplistic I know but why not start the debate here.
In an overly simplistic way
IMU when developing its trial structures from Phase 1 to Phase 2/3 surely it obtained how many patient numbers it required and a criteria FDA would call successful enough to get approved.
If we knew that we could estimate our own time frames base don number of patients and what FDA deemed success.


IMU keeping shareholders in the dark is plainly disrespectful.



Anyhow something to ponder whilst we hang around in the dark waiting for data