It’s a great company with exciting developments in the use of dendrimers. After very strange negativity from TGA about Viraleze under the Morrison Govt 2021 when Viraleze was banned, there is a potential turn around on 7 Dec when the ACMD meets to consider TGA delegates report on Astodrimer sodium nasal spray (that is VIRALEZE by SPL).
https://consultations.tga.gov.au/tga/scheduling-pre-meeting-november-2023/user_uploads/pre-meeting-public-notice-acms-43--accs--37---joint--35-november-2023.pdf35 regulators around the world have approved Viraleze as a MD (medical device) so Australia is an oddball, stand out against it. Europe EMA approved in first year of pandemic in Nov 2020 and the SPL stock rose to over $2 in early 2021 until the TGA ban hit which wasn’t based on any Astodrimer sodium safety issues but related to accessibility of STI sufferers to Astodrimer sodium BV treatment and because the companies website to buy Viraleze on line is visible to Australians. Even though as many here will attest we have to use legal TGA PERSONAL IMPORTATION SCHEME via friends in UK, EU, NZ, HK Vietnam etc just to buy Viraleze which has protected many of us from getting covid. Unlike the other less effective antiviral nasal spray ENOVID from Israel whose online sales are viewable and useable by Australians, for Viraleze Australian IP addresses are blocked from seeing the real Viraleze.co site. So what TGA has against Australians exercising their legal right to purchase unapproved therapeutic goods seems like a vendetta of some sort
So next weeks AGM and the decision on 7 Dec means we live in very exciting times - it’s been a long time. On this forum you will find many frustrated shareholders blaming management, my take is rather different and I think Viraleze was too good, selling well, which was made by small pharma Aussie SPL just as Pfizer was entering phase1 trials of PF-07321332 Paxlovid which was going to be very expensive so would have been gazumped. At that time Morrison was secret second Health Minister and TGA boss Skerritt said that they awaited a signal from govt before considering applications (Sep 2021) and Morrison was desparate for earlier mRNA vaccines because of the AZ problem.
Welcome - you will see the reactions to this post I’m sure. I’m also looking forward to the new CEO and to the long hard work of JF who gets a well deserved retirement
