RE: The patent Cliff for big Pharma31 Dec 2023 13:09
Afternoon / Prynhawn Da welshfalcon ❤️🏴. An important point, I believe mentioned by BV, but definitely by someone. Totally supportive of your comment.
Not trying to teach people to suck eggs…
AVA6000 will come to market with a Product License stating approved indication for use and dosing regimen. Let’s say it’s Soft Tissue Sarcoma - but only STS initially.
The oncology community will want to either use AVA6000 off licence, or will rapidly set up trials that show AVA6000 is effective in other cancers, and seek to get the PL expanded. All this will cost Avacta is a supply of the drug if not being bought at cost price.
The OxyContin / Purdue Pharma, and off licence use of Pregabalin, has brought into question the licensed and off licence regulation of drugs. It’s being taken more seriously than ever. Obviously AVA6000 is not a drug of misuse, but the efficacy and safety profile must be established for any new indication. Thankfully, there are well established systems for off licence use of drugs within the UK / NHS. So time will tell us which route is taken. But it’s going to be very interesting. I wonder if individuals will have biopsies taken to establish the FAP level present, or if this is necessary?