I am not going to go through this post line by line but it has lots of red flags IMO.

DYOR on the below post as it contains misinformed statements that are 100% incorrect , misleading with lots of assumptions and a spin of conspiracy especially in regards to Viraleze. .
SPL has IMO used a backdoor ( now closed) CE approval as a device in EU when UK was a member and has used recriprical arrangements to extend that approval to other bodies. SPL however has failed to actually get distributers in key markets and in other markets has chosen IMO distributers who have performed poorly. The MRHA has required SPL to do a post market study for Viraleze and the readout of that study is pending sometime as trial has closed . IMO the study design and scale may not satisfy requirements that some think.. Should that study fail to be sufficiently powered it IMO would cause a cascade of all recripical approvals to be reviewed?

SPL has chosen a pathway for Viraleze and to date the execution and resulting sales have been poor for a multitude of reasons and until a trial with suitable power has been published then it will remian in marketing limbo unable to make claims in key markets and IMO distributers will avoid it.

Have a look at FRE and you will see different pathways being tried for different products and the difficulty they have recently encountered with a failed trial ( poor design etc etc) .

The TGA etc all have pathways and provide plenty of feedback to companies in regards to applications but I don't believe it is a conspiracy for or against a particular product . IMO you have to expect some pushback trying to have a product apporved using a new dendrimer and butting heads with key approval bodies when trying to do so without human trials . The key viraleze question is if the trial is positive , is it powered enough to make a particular claim that will satisfy various approval bodies? . Not as simple as some present thinking that Viraleze works for them ( after a private import) so it should be avaliable for everyone. No one knows if Viraleze outside of a petrie dish or animal tests if it works in real life in humans yet nor to what extent and what qualifications.

I hope trial is sucessful and that positive Viraleze result is able to be published however shareholders remain unaware if that will be only suitable to continue MHRA approval or will be acceptable to support TGA application etc. SPL has given no feedback to holders so they are in the dark of their expectations

There is a lot of serious questions regarding the above that should be asked and answered at AGM and I was hoping trial results would have been out by now so SPL management couldn't avoid them for another year.


Starlink I was notified about a recent cringworthy post of yours pulling the gender victim card ( not the first time) and somehow calling bias and frankly your allegation is baseless, insulting and disgusting and says a lot more about yourself than me. I don't care what sex a employee is and my analysis was based on my opinion of public qualities , experience and qualifications at what $ value compared to experience and skillset I believe will drive the business. Doesn't mean the applicant can't do it I just believe SPL board should have found an applicant who had already done it as it is a critical time in SPL development while they still have some $ and can pivot should current agreements and pathways fail.

"Oh I forgot negative Neil’s don’t see female qualifications and experience - their eyes glaze over any female gender.

Certainly not an assessment sensible readers would consider valid "

"
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.pdf

35 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 "