Replies to post #262652 on Anavex Life Sciences Corp (AVXL)

[Biostockclub]

Great point, Sharkee!

[Pazzo1212]

It’s also a testament to the doctors who see the benefit and patient improvement, and have recommended the continuation of the drug. This is not a company’s spin but a set of specialist doctors willing to ask their government to allow its continuous use. Because it’s the best option available to their patients and it’s working!!

[powerwalker]

Thank you, Shark, and, Bio, for all your work and to everyone else, too ... Too many to name ... you know who you are.

WE GOT THIS!!!


ANAVEX NOW ... RIGHT NOW ... MONO-STYLE ... for LIFE ... and for ALL AGES!!!

[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.

[nidan7500]

Sharkee2

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 for the process efficacy and safety of the drug. Whenever eventually we apply for general marketing approval, it should be done in a cinch.

Of critical importance here w/this news is the trail of validation being proven by safety, and trial results. The Validation of the CNS Homeostasis thesis is of massive consequence, BP is in deep shat.. Dr.M. has worked a Trifecta win (AD/RSD/PDD) all supported by rigorous discipline from WW (multicultural/multinational) exceptional Precision Medicine work.

The results do look promising at this point for validation and subsequent indication specific treatment approvals. Validation (proof according to a documented/validated protocol with provision of objective evidence) is a universally accepted concept by regulatory bodies. They have done the proper work (see NCT string) which will very likely be recognized as a bases along with RWE-RWD-PIII level work, even by FDA). We also must consider the WW need as a compassionate factor, along w/academic support for the bio/med-concepts, see safety history. Nothing at all like current toxic treatments. We sure got this.

Politicians and BP corruption will go nuts when they see and realize their cash cows being taken away, IMO.