On this quiet Sunday morning with very little news to discuss it...

On this quiet Sunday morning with very little news to discuss it seems opportune to discuss the potential for one or more of Imugene therapies to receive Accelerated Approval.
We certainly have been accumulating relevant data to apply for this.
Let's look at what FDA says about AA;

The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and fill an unmet medical need based on a surrogate endpoint. A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit but is not itself a measure of clinical benefit.

The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval.Drug companies are still required to conduct studies to confirm the anticipated clinical benefit. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. If the confirmatory trial does not show that the drug provides clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market.

CF33 + hNIS in the MAST trial will now have accumulated some valuable data, as Leslie has said, "it is the gift that keeps on giving", and as was announced at on of the conferences;
Immunological changes in CF33-hNIS responding patients show a robust innate andadaptive immune response known to promote anti-tumor immunity andunderscores the immunomodulatory potential of this therapy.
This looks to me to meet the criteria of a surrogate endpoint!
In the OASIS trial we are sure to see similar activity to the MAST trial, so another opportunity for an AA could present itself sometime this year.

CF33 + CD19 protein along with acer-cel has been shown to destroy multiple tumours 100% of the time in pre-clinical tests, and as Paul Glover mentioned in one video he has seen a lot of these tests and never seen results this good.
The combination of these 2 drugs possibly next year in patients could result in data never seen before in solid tumours, 90% of cancers being solid tumours.
With the increase in M & A activity taking place now Imugene could be on many a BP radar if either Fast Track and/or AA is given for this treatment.
However the cards fall Imugene is in the mix and cannot be ignored by BP and investors alike.

DYOR opinion only