new ann 14-sep11, page-13

from an old email from MR 29th April 2011

" ... 1. Yes CVac is used outside trials current in Australia under the SAS scheme. Currently it is as a compassioned use. Results show certain activity for CVac but I have to caution that it is normal to do larger controlled studies to show statistical significance across a lot of patients. "

and from the Australian Government Therapeutic Goods Administration
website


" About the special access scheme

The SAS refers to arrangements which provide for the import and/or supply of an unapproved therapeutic good for a single patient, on a case by case basis. Patients are grouped into two categories under the scheme:

Category A patients are defined as 'persons who are seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment'.

ref

http://www.tga.gov.au/hp/access-sas.htm#about

cVac is recognised as a ' blood plasma ' type product in Australia ( and Dubai ) and is thus not subject to the rigours of Therapuetic drug approval ( or similarly FDA in the US )