Yes - excellent post, zero.
I can see why friend
@bavarian1975 would read Nick's reply and think that we are still years away from commercial success, but I agree with your analysis. If CF33 really works in humans even half a well as it works in pre-clinical animal studies, or even a quarter as well, then that will become very clear very soon in the current dose escalation trials and the FDA will move towards accelerated approval.
Under Accelerated Approval CF33 would be approved for commercial use ahead of a normal Registrational Study. The further studies would till need to be undertaken - but CF33 could be put into the market immediately, ahead of obtaining data on Overall Survival, as long as it was clearly producing interim results which are likely to result in improved overall survival. For example - shrinking or killing tumours.....
https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/accelerated-approvalWe already have strong hints from Prof Fong that CF33 is performing in humans the way it did in animals, and Nick Eade has just confirmed that the tumour necrosis pic in last week's AACR conference presentation is indeed regarded as direct evidence of CF33 killing cancer.
It will take more than one example of a necrotic tumour to convince the FDA, but the data in the AACR presentation was for patients at low dose levels - just two of them at Cohort 3. It will be fascinating to see what happens at Cohort 4 or 5, and what they determine as the Optimal Biologic Dose. And then in the Vaccinia trials we have only just started Cohort 3 - the very beginning of dose levels where we might expect to see therapeutic effects.
When interim data is finally published, later this year, we will see the truth. If those results reflect Yuman's hints, then Accelerated Approval will definitely be Imugene's goal and it will be "game on" for commercial offers.
Nothing is certain, but the indications so far are all very encouraging.
Cheers
Dave
(20min delay)