Anavex Life Sciences Corp (AVXL)

[XenaLives]

TGA requirements have been discussed for years here.
OLE's may be as valuable as a trial for the purpose of Provisional approval.

One more time:

XenaLives Member Level Monday, 08/31/20 09:52:03 PM
Re: None 0
Post #
268220
of 271856
From the TGA:

Provisional approval of prescription medicines
20 June 2019
Provisional approval allows us to approve some prescription medicines for a limited period of time while more research is conducted.

We use the provisional approval pathway when a new medicine is a promising treatment for a serious or life-threatening condition but there is less research available on the medicine than we would normally require for the approval of a prescription medicine.


This is all that Anavex has to do to qualify:

Eligibility for provisional approval
Provisional approval provides early access to promising new prescription medicines for serious and life-threatening conditions. However, it is important to be aware that our knowledge of the risks and benefits of these medicines is less certain than other approved prescription medicines.

There are a number of eligibility criteria for the provisional approval. Most importantly:

it must be a new prescription medicine or a new indication for an existing medicine
it must provide a favourable comparison against existing therapeutic goods
it must provide a major therapeutic advance
the sponsor must provide evidence of a plan to submit comprehensive clinical data.

This is the evidence required:

Research, evidence and safety for provisional medicines
All medicines have side effects. However, when a medicine is new to the market it is impossible for us to know all the possible side effects. Although evidence is still being collected on the medicine, we have assessed the available data and made a decision based on that. To ensure the safety of provisionally approved medicines to the best of our ability, we will:

make sure all available evidence shows that the benefits of the medicine outweigh any risks
ensure all applications for approval include a plan on how the drug company will conduct more research on the medicine’s safety and efficacy
monitor the medicine more closely so that any issues are identified
limit, suspend or cancel the approval if there are major patient safety concerns.

Providers are required to report ALL side effects:

Report all side effects
Because data about provisionally approved medicines is still being collected, it is very important for both patients and health professionals to report all side effects.

Report all side effects directly to the TGA through our online form.


The above can all be found here:
https://www.tga.gov.au/hubs/fast-track-approvals/provisional-approval-prescription-medicines

The last item on this page is this:

Subsidised medicines through the PBS
Subsidies are determined and administered by a different section of the Department. For more information about how prescription medicines are subsidised visit the Department of Health’s Pharmaceutical Benefits Scheme webpage.

Which links to this page and I can see no reason why Blarcamesine would not be covered under the Aussie's single payer plan:

Who is eligible for the PBS?
The Scheme is available to all Australian residents who hold a current Medicare card.

Overseas visitors from countries with which Australia has a Reciprocal Health Care Agreement (RHCA) are also eligible to access the Scheme. Australia currently has RHCAs with the United Kingdom, Ireland, New Zealand, Malta, Italy, Sweden, the Netherlands, Finland, Norway, Belgium and Slovenia.

Residents of these countries must show their passports when lodging a prescription to prove their eligibility or they can contact Services Australia and get a Reciprocal Health Care Agreement Card to prove their eligibility. Some overseas visitors may not be eligible for this card.

Only those eligible for the PBS will receive subsidised medication and every time you present your script to the pharmacist, you will need to provide your Medicare card.

Eligible veterans may need to present their DVA card in addition to their Medicare card.

With your consent, the pharmacist may (at their discretion) keep a record of your Medicare number so that you do not have to show the actual card every time you lodge a script

https://www.pbs.gov.au/info/about-the-pbs

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