Believe what you may want to...I think the approval is for any AZ patient under the care of a physician who can make a request with proper paper work. The company cannot advertise SAS, so it only talks about the patients under the trial now for 5 yrs. As the IR has confirmed, anyone can apply and get approval (as long as they can justify). I highlighted few things from the PR the other day which are worded in a way not limiting the reach. My inserts/thoughts in RED.
Compassionate Use Special Access Scheme Approval for Alzheimer’s Patients to Continue Treatment with ANAVEX®2-73 (blarcamesine) after Completing the 5-Year ANAVEX®2-73-003 Phase 2a Clinical Study
They cannot advertise, so they can comment only on patients in trial
NEW YORK, Aug. 05, 2020 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) diseases, today announced that patients from the ANAVEX®2-73-003 phase 2a Alzheimer’s disease trial will continue treatment with ANAVEX®2-73 (blarcamesine) via the Australian Government Department of Health - Therapeutic Goods Administration (TGA) compassionate use Special Access Scheme following completion of over 5-years daily dosing of ANAVEX®2-73 (blarcamesine) and recommendation by their physicians.
The TGA approved the Special Access Scheme Category B applications based on the safety profile of ANAVEX®2-73 (blarcamesine), as well as clinical evidence that ANAVEX®2-73 (blarcamesine) may benefit patients. Anavex will facilitate continued access to ANAVEX®2-73 (blarcamesine) through the Special Access Scheme at the physicians’ request.
Again, cannot advertise or market. This doesn't preclude Anavex from facilitating it to other AZ patients if there is enough interest and TGA approves requests from the physicians
“We are honored to support medical professionals and their patients seeking treatment for Alzheimer’s disease and who have very few medical options,” commented Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “The Phase 2a clinical ANAVEX®2-73-002/-003 studies are exploring the long-term effect of daily treatment with ANAVEX®2-73 (blarcamesine) over 5 years, however it is pleasing that physicians have requested extended treatment of their patients with ANAVEX®2-73 (blarcamesine) beyond these 5 years.”
The participants (physicians and patients) made the request to make this SAS approval possible, but it doesn't stop others from applying. In the past, the extensions were just announced as such..not as SAS. So, why this approval now and how is it different from other extensions?
The Special Access Scheme:
Most therapeutic goods are required to undergo an evaluation for quality, safety, and efficacy, and be included on the Australian Register of Therapeutic Goods (ARTG) before they can be supplied in Australia. In recognition that there are circumstances where patients need access to therapeutic goods that are not listed on the ARTG, the TGA facilitates a Special Access Scheme (SAS) for physicians seeking to use medicines that have not yet been approved in Australia. The SAS refers to arrangements, which provide for the supply of an unapproved therapeutic good for individual patients. Applications under the SAS are made to the TGA by their treating doctor, and approval to treat the patient takes into account the safety of the drug as well as supporting evidence that the drug may benefit the patients, along with the failure of any current therapies.1
So, with this SAS approval, physicians and doctors can get the medicine even though the medicine is not in ARTG
