Filana Therapeutics Inc (FLNA)

[tootalljones]

TWELVE MONTHS BLOWS AWAY THE SOC....A couple thoughts. While the open label trial is not the phase 3 blinded double placebo thing, it should be noted the primary reason for the placebo patients is to get the baseline (i.e. see a diseased population in the identical setting as the dosed population.) Once you get the diagnosis, then you gotta see that population compared to the drug candidates that are dosed in an identical setting.

And you gotta take into account the fact that the non dosed patients will often exhibit a placebo effect. However, nobody disputes that in Alzheimers disease, the placebo effect does not last very long, and far under a year, far far under.
This means we know by now that SAVAs drug is blowing away the current standard of care drugs (which are lousy-- basically marginal effectivness for 4 months,...very marginal, in fact hardly noticeable, at which time the disease continues it fatal progression).

The question is, when our drug shows in 3 more months excellent effectivenss (mind blowing, excuse the expression..), won't the company want to get the thing approved then and there? We will have 3 more months of safety, and given the origninal phase 1 trial, it is prety clear the drug is safe. What is stopping an application in this fatal disease, to the FDA for consideration of early approval? We have a fatal disease, nothing else approved can even effect, which is being now stymied if not "cured." Why would the FDA not consider in 3 more months, or 6 more months, approving it, bearing in mind the millions who are dying from it? Assuming the next 3 or 6 month open label disclosures are still "positive."

Where is the patient's right to choose? If I had this disease right now, I would demand the drug be adminstered to me, to stop the disease from growing. In a cancer trial, 12 months of great results or 15 months (even 9 months, and probably even 6 months) would surely result in the trial being halted and the drug start being given to millions.........At what point was the cancer blockbuster taken out of normal testing and given special treatment? I am sure ketuda did not have to wait a year, once it was clearly established the drug was safe and effective. It was given BDT.