Hi Chambo
as a superheroes offspring I'm mandated by birthright to continue to save the world from evil villians, which our beloved MM has not yet made the grade. Possibly, not long now though.
Regarding the payments to CRO(s) for data analysis, I think it should be the least of our concerns. Like most contracts, the price would have been settled prior, yet can possibly change if unforseen circumstances arise. Such a scenario in this case would be certain data raises new questions beyond the initiasl scope of the contract require an ajustment to the contract terms. I have no idea if this applies in our case. I suspect I'm afraid that the delay is just as MM has stated, 'complex.' I'm personally not too concerned about the delay or the funding. But I'm a forgiving marsupial.
But with that said, it is worth considering how the analysis of the data can play out. Generally speaking without referring to the specific hopeful outcomes themselves, there are hypotheses trying to be demonstrated from the data. To establish these the first requirements are the successful attaining of the trial design endpoints. The endpoints in themselves are not the end of the process. Rather, they are more the beginning of the real analysis, that is, the demonstration of the hypotheses. Ther endpoints are milestones achieved in a complex process, like the repainting of an old car. First end point is to remove all dings, second is to prepare the entire surface, third is to have it spotlessly cleaned, and lastly is to make paint stick to the batmobile, which daddy seems to undo on each outing. The hypothesis being that paint is better than batship. Still a work in progress.
Acheiving the endpoints are key developments in painting a better picture of how BIT225 is 'erradicating' HIV, ditto SARS2. Even though the endpoints are somewhat fixed, at least in terms of defining the scope of the trial, the data necessary to demonstrate such may reveal more than the establishment of the endpoints. It may raise new questions worthy of consideration and therefore cause the need for the brain boffins to think outside the proverbial box to draw better or broader conclusions. Let's not be mistaken here. If the endpoints are well achieved, the initial hypothesis is well on its way to being demonstrated, but I'd be very surprised if every aspect of how erradicating either indication if fully understood. That will take further work. What Biotron is trying to achieve here is a better understanding of what they thought they knew, so that everyone else can now know what Biotron know now, expecially those who need to know, which is of course a potential partner for phase three trials .
Not Nong Now.
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