Replies to post #401046 on Anavex Life Sciences Corp (AVXL)

[Hoskuld]

Rett trial was done in USA. AD trial was done in Australia, NZ, Canada, UK, and EMA. PDD trial was done in EMA.

This means that each regulatory agency (FDA, EMA, Australian and NZ and Canadian and UK agencies) can point to safety and efficacy data that was gathered under their auspices and in their own country's clinics. This was very smart and clearly deliberate.

Anavex is looking to provide working therapies to patients globally, not simply to the US market alone.

[WolfofMia]

Why AVXL does trials oversea?

Easy question, the overseas countries have a single payer medical system (the government).

Therefore, approval is harder for any drug in any of those countries according to:

From Breakthrough to Blockbuster: The Business of Biotechnology
by Donald L. Drakeman (Author), Lisa N. Drakeman (Author), Nektarios Oraiopoulos (Author)

So once we get approval there it will be easier for FDA to approve if not at the same time or before.

There are also many tax incentives in these countries for the same reasons stated above.

And the population is perfect since it includes all of American descendants in terms of genomic varieties.

Why AVXL do Rett trial oversea ?

Because BIIB Best buddy Crook FDA

FDA won't let AVXL do trials in US
So we do Rett in AUS CN UK
Do Parkinson in AUS EU
Do AD in AUS CN
FDA always Holding back Anavex

BIIB afraid Anavex will take over all CNS AD market

Is not the other way around, Europe and Australia have higher standards of drug approval than FDA because the medicines are not paid by private payers (insurance companies), but by government.