General discussion, page-7644

Thanks for sharing the experience with ZLD.
I think the biggest issue with uptake when a drug is available via the SAS, is that doctors are motivated to use them only as a last resort, and if they feel they are very familiar with the formulation and the risk/benefit profile of the treatment.

The TGA stipulates that: "The prescribing health practitioner also accepts responsibility for the use of an 'unapproved' therapeutic good and any associated adverse reactions."

https://www.tga.gov.au/form/special-access-scheme

Also, only a subset of physicians are registered to make SAS applications or notifications, in order to open up access for their patients.

Still, there will always be, among those physicians, a number who will see a net positive in gaining access to a new drug for specific patients who they believe will benefit. For OSA sufferers who have tried CPAP and rejected it, there is a good chance the doctors who are already prescribing CBD via the SAS will be comfortable enough to prescribe IHL42X to alleviate their patients' OSA condition. If the drug is really effective and presents a minimal, or even just tolerable side effect profile, there will be a real buzz considering the lack of treatment options for this condition with serious ramifications. I would expect, within the very real confines of the SAS pathway, a relatively rapid uptake if the drug really works.

Also good to remember that the SAS is not all about revenue for a clinically developed therapy like IHL42X. The pay day will come with regulatory approval in various markets. But the SAS provides an on-going stream of patient data that gets folded into the process of seeking regulatory approval.