Anavex Life Sciences Corp (AVXL)

[Doc328]

There are actually two less steps in the US than in Australia. There are only 3 parties involved in the US (patient/doctor/pharmaceutical company) instead of 4 parties in AU (patient/doctor/Government/pharmaceutical company).

I wonder if Anavex has received requests. Many companies don't participate in early access schemes like RTT and SAS because risk of deaths for non-trial patients (even if not related to the study drug) muddies the water for approval.

In US:
1. Patient (and/or caregiver) and doctor agree that trying a drug is worth the potential risk
2. Patient/caregiver sends a letter to the drug company
3. Drug company agrees or does not agree to provide a drug for free or for a price without profit

In Australia:
1. Patient (and/or caregiver) and doctor agree that trying a drug is worth the potential risk
2. Patient/caregiver send in the SAS Cat B 2 page application to the TGA
3. The TGA either agrees or does not agree to allow the access.
4. Patient/caregiver or doctor (not clear who requests) sends a letter to the drug company
5. Drug company agrees or does not agree to provide a drug for free or for a price

In US, a phase 1 must have been performed and patient is ineligible for an existing trial. The FDA plays no role in the RTT process as long as phase 1 has been performed.

In AU, a phase 1 is not necessary. Point is moot as A273 has phase 1 (and also 2a data)