Anavex Life Sciences Corp (AVXL)

[falconer66a]

What could the TGA be thinking?

More than the revenue, it is the fact that a government body has recognized that this drug can be prescribed post trial. This is a validation of the efficacy and safety of the drug.

Ok, the Australian Therapeutic Goods Administration (TGA), their Food and Drug Administration (FDA), just approved the continued prescription of blarcamesine for Alzheimer's patients who have been previously dosed with the Anavex drug in the continuing clinical trial.

How so? What were the TGA poohbahs thinking when they did this? Don't they know that blarcamesine is dangerous, never fully tested, and can have only placebo effects when prescribed on open (known) label status? Don't they read the postings of the Anavex experts here?

Or, perhaps, might they actually realize that, indeed, the continued, post-trial use of the drug has yielded positive, desired clinical results, absent any obviating side effects? If that's so, what will keep them from eventually granting some sort of provisional approval (PA), allowing physicians to elect to prescribe it for any selected patients (who would be subsequently monitored)? In Australia, those would be many thousands, of course.

Would the TGA authorize the sale and use of an unsafe, ineffective new CNS drug, even for just a few dozen people who have already been taking it?

Lastly, how would the TGA people eventually explain just why they rejected any general, conventional sales and use approval for the drug, after previously (just now) allowing the drug's use in a certain population? Seems pretty certain; things are being set up for a provisional approval (PA), if not full use approval.