A synergistic accident?
Just a theory.
If TFF was incorporated into the trial at some point to decrease chance of contamination, increase potency per dose and reduce dose volume per injection, the latter two aspects may have increased efficacy more than expected.
There are different ways to increase product yield, and one is to increase cell potency so that not as many cells need be used per dose.
If not as many cells are used per dose, two things might occur.
1. More dose administrations are available so that a patient can receive doses from one batch for a longer period of time.
2. Dendritic Cell migration increases.
Dendritic cell migration + more potency = more efficacy?
Perhaps. Particularly when the cells that are no longer injected were the ones that prematurely activated.
Anyway, something to consider is that the FDA and SEC tend to box in uninformed or reckless companies.
1. The FDA will nail them if they release good results prematurely. They might make you do another trial.
2. The SEC will nail them if they do not release bad results within a matter of days.
It's a bad deal for investors, because it tends to shove good news into the abyss for some unpredictable length of time, and tends to expose bad news before it can possibly be remedied. This impact is likely amplified in smaller biotech companies with limited pipelines and resources.
The fact that NWBO has not released any news, on the PSH, may also simply mean no news has yet definitively occurred.
If changes in the trial occurred that caused the synergy discussed earlier in this post, then why not share the good news that PFS eventing is slowing down?
The possibility of such a positive scenario might be explained, perhaps, by the fact that such synergy might actually cause excellent results that were not expected and therefore can't be immediately interpreted and therefore can't be immediately disclosed.
Under the best case scenario, I can envision later placebo patients crossing over, and if the potency was increased while the dose was lowered, some patients who were thought to have tumor recurrence, actually respond to DCVax-L by exhibiting tumor shrinkage and/or complete response.
This would not be immediately explicable from a scientific proof point of view, because it would need to be distinguished from potential misdiagnosis of progression versus pseudoprogression. This would require use of the latest validated diagnostic technology and protocol.
Fortunately, any phenomenon like this might be easier to resolve because the earlier patients' blood cells in the trial who did not receive TFF would provide a sort of baseline to the latter changes. Just tossing it out there.
Respect Risk. Conduct Your Own Due Diligence. Manage your assets wisely. Diversify.
