A randomised trial that should have been done decades ago has found more deaths among critically ill flu patients given Tamiflu than among those given no antiviral.
And, the consequences to drug companies for withholding important research data is ... PROFIT. Simple law of behaviour: behaviour that is rewarded is repeated. The negligence of elected officials in congress and parliament is shameful, if not criminal.
Is it any surprise that another pharmaceutical product proves to be an elaborate hoax? Scamiflu is just another in a long series of overhyped pharmaceutical products. When will we ever learn? The shame is that although well over 90% of pharmaceutical products are all but worthless, and many harmful, a small percentage contribute measurably to the health and betterment of humanity. None of them, with rare exception address root causes of health problems, prompting some such as Oliver Wendell Holmes to quip that the entire pharmacopoeia could well be thrown to the bottom of the ocean and it would be so much the better for mankind, and so much worse for the fishes.
Thanks for those observations, JR. I presume some of those issues you mention should be ironed out by the randomisation—which is why RCTs are so important when trying to work out whether a treatment actually works (or harms).
Let’s face facts antivirals via systemic blood stream do not work. The virus outplays them once it crosses into human systems. Early treatment in first 5 days and preferably day 1 or by regular 6 hourly antivirals are needed like acyclovir cream for cold sores AS BARRIERS not via the stomach to the blood stream
Drug companies love AV DRUGS because once approved by regulators like FDA TGA the barrier to entry of competitors is based on cost of efficacy trials AS LONG AS THEY CAN DISMISS BARRIER AVs
My expertise is covid - (1) Paxlovid, (2) Lagevrio both systemic expensive drugs, (3) surface antiviral nasal spray VIRALEZE™ and (4) surface bronchial antiviral protease inhibitor punicalagin via lozenge or slow barrier absorption.
3 and 4 pass efficacy. 1 and 2 in vaccinated vulnerable fail
And 3 and 4 are safe longterm and not absorbed
Pfizer is still today trying for replacement of (1) with PF-07817883 Ibuzatrelvir but 2 years into trials nothing to announce - a case of hope turns to hopeless where they realised the HIV drug in the Paxlovid pack has too many drug interactions and adverse side effects that another drug was needed.
This Grok info today may interest readers
Question of Grok:
EPIC SR (Pfizer’s Paxlovid trial for vaccinated vulnerable) is what should advise/inform GPs and those in community health that drugs have no efficacy. The $2B in Australia was COMMUNITY HEALTH AUTHORISED SOLUTION including routine widespread use of Paxlovid and the failed Lagevrio in aged care nursing homes with nurse practitioners allowed to prescribe.
Now in Victoria they are running trials of UV lights (like they use on meat in butchers shops) in nursing homes whilst TGA still stops Australians buying Astodrimer sodium nasal spray SUMP Sched 2 ie VIRALEZE™ when it’s RCT study was requirement of UK AUTHORITY and conducted in NHS Hosp.
TGA behaviour is detrimental to 18 million Australians
♨️Grok♨️
**EPIC-SR is highly relevant to community and primary-care prescribing.**
It showed no meaningful shortening of symptom duration in standard-risk patients or vaccinated patients with risk factors, and no statistically significant reduction in hospitalisation/death in that population. This supports more selective use by GPs and community clinicians rather than routine widespread prescribing, especially given the known drug–drug interactions (including with many cardiovascular medicines).
### Australian spending and aged-care use
Government expenditure on Paxlovid (nirmatrelvir/ritonavir) and Lagevrio (molnupiravir) exceeded $2 billion between mid-2022 and mid-2025. These were PBS-listed for community use and extensively prescribed in residential aged care, including by authorised nurse practitioners. Lagevrio’s original trial evidence was weaker (≈30% relative reduction in severe outcomes) and later real-world/RCT data have been even more limited. Residential aged-care residence itself is listed as a risk factor that can meet PBS eligibility.
### Victorian UV-light trials
Victoria is running the ELUCIDAR study: a cluster-randomised trial of upper-room germicidal ultraviolet (UV-C) lighting in common areas of 61 residential aged-care facilities in Melbourne and Greater Geelong. The lights were switched on from November 2024 for a 12-month period to test whether they reduce COVID-19 (and other respiratory virus) transmission among residents. This is an infection-control environmental intervention, analogous in principle to UV disinfection used in other settings (including food processing).
### Viraleze / astodrimer sodium status
The UK post-market randomised, double-blind, placebo-controlled trial of Viraleze (astodrimer sodium nasal spray) was conducted in NHS hospitals under UK regulatory requirements. It reported statistically significant reductions in nasal SARS-CoV-2 viral load (especially in participants aged ≥45), faster clearance, and improvement in some symptoms such as loss of smell, with good tolerability.
In Australia the product is not on the Australian Register of Therapeutic Goods (ARTG) for marketing. Starpharma recently withdrew its application after a prolonged process that involved disagreement over whether it should be regulated as a medicine or a medical device. Astodrimer sodium remains scheduled such that the nasal-spray product is not freely available as a Schedule 2 pharmacy medicine for this indication. Personal importation and direct shipping from overseas sites have been restricted for Australians.
Regulatory decisions on Viraleze differ from those in the UK and other countries where it is sold. Whether that difference is “detrimental” is a matter of policy judgment; the TGA’s position has centred on classification, evidence package for the intended claims, and the Australian scheduling framework rather than a finding of safety concerns with the substance itself.
EPIC-SR data, the large public spend on the oral antivirals (including in aged care), the Victorian UV trial, and the non-availability of Viraleze in Australia are all factual elements of the current picture.
📌My comment 📌 EU MDR
VIRALEZE
European medical device regulations February 2025:
Earlier this month, Starpharma received certification for Viraleze™ under the new European Union (EU) Medical Device Regulations (MDR). Under the new EU MDR classifications, medical device manufacturers must demonstrate compliance with certain essential
requirements and undergo a new conformity assessment process with a Europea pd
Notified Body. Achieving EU MDR certification demonstrates that Viraleze™
and the research supporting the product meet the necessary safety and performance
♨️Grok♨️
**Thanks for the detailed clarification and the additional context from your discussions with the company.**
Public records align with the core timeline you describe. Starpharma’s own 2025 Annual Report states that in October 2024, after a long TGA review process and careful consideration of expert legal and regulatory advice, the company withdrew its application for marketing authorisation of the SPL7013 (astodrimer sodium) nasal spray in Australia.
Your account of the regulatory trigger (changes affecting Class 1 medical-device pathways, with implications for a potential new Class IIa application) is consistent with broader TGA medical-device classification reforms that took effect or had transition deadlines in 2024. Substances intended to be introduced into the body (including via the nasal cavity) can fall under higher classification rules requiring more extensive conformity assessment. Withdrawing the existing application so that any future filing could more cleanly reference the later EU Notified Body certification is a commercially rational step, especially for a company managing limited capital.
The image you shared matches Starpharma’s achievement of certification under the new EU Medical Device Regulation (MDR) in early 2025 (February per your note). That certification demonstrates compliance with the updated European safety and performance requirements and supports continued or expanded marketing in the EU and related markets.
You also note the company’s capital position at the time (low cash reserves prioritising the dendrimer oncology programs that require Phase 3 work) and the subsequent capital raise, plus the share-price recovery. Those commercial realities help explain why the board chose not to pursue a potentially complex and resource-intensive TGA Class IIa process at that point. A future Australian application remains possible but is currently on hold.
### Access for Australians
Viraleze remains unapproved for marketing in Australia (not on the ARTG). Personal importation of unapproved therapeutic goods is subject to TGA rules, quantity limits, and other restrictions. Some overseas suppliers (including the one you mentioned) will ship to Australia, but buyers should be aware of the legal and practical constraints, potential customs issues, and the higher cost.
Your X group efforts to help people source legitimate product and to warn against scammers are a practical response to the current regulatory situation.
The combination of the EU MDR certification, the UK NHS trial data, availability in many other countries, and the deliberate withdrawal of the Australian application (driven by classification changes and resource allocation) is the current factual position. Whether or when Starpharma re-files with the TGA will depend on future commercial and regulatory calculations.
Really Rotten Ruinous Ripoff Recidivistic Rapacious Rascals ! 🤧
And, the consequences to drug companies for withholding important research data is ... PROFIT. Simple law of behaviour: behaviour that is rewarded is repeated. The negligence of elected officials in congress and parliament is shameful, if not criminal.
Moreover, the penalties for failing to disclose drug harms are not large enough to deter this kind of behaviour.
Is it any surprise that another pharmaceutical product proves to be an elaborate hoax? Scamiflu is just another in a long series of overhyped pharmaceutical products. When will we ever learn? The shame is that although well over 90% of pharmaceutical products are all but worthless, and many harmful, a small percentage contribute measurably to the health and betterment of humanity. None of them, with rare exception address root causes of health problems, prompting some such as Oliver Wendell Holmes to quip that the entire pharmacopoeia could well be thrown to the bottom of the ocean and it would be so much the better for mankind, and so much worse for the fishes.
Hi, I had a couple of issues with the study:
- started march 2020, covering both covid vawes and intervention vawes
- they improved analytical precion en route -moving the posts?
- they excluded prior vax recipients. Why throw bad medicine after this initial set did not prevent hopsitalation?
- apart from that injection decision, no interes in covid injectables, nor latest coronavirus infection
- they never even mention corona or covid shot.
The results, however, were clear.
JR
Thanks for those observations, JR. I presume some of those issues you mention should be ironed out by the randomisation—which is why RCTs are so important when trying to work out whether a treatment actually works (or harms).
Let’s face facts antivirals via systemic blood stream do not work. The virus outplays them once it crosses into human systems. Early treatment in first 5 days and preferably day 1 or by regular 6 hourly antivirals are needed like acyclovir cream for cold sores AS BARRIERS not via the stomach to the blood stream
Drug companies love AV DRUGS because once approved by regulators like FDA TGA the barrier to entry of competitors is based on cost of efficacy trials AS LONG AS THEY CAN DISMISS BARRIER AVs
My expertise is covid - (1) Paxlovid, (2) Lagevrio both systemic expensive drugs, (3) surface antiviral nasal spray VIRALEZE™ and (4) surface bronchial antiviral protease inhibitor punicalagin via lozenge or slow barrier absorption.
3 and 4 pass efficacy. 1 and 2 in vaccinated vulnerable fail
And 3 and 4 are safe longterm and not absorbed
Pfizer is still today trying for replacement of (1) with PF-07817883 Ibuzatrelvir but 2 years into trials nothing to announce - a case of hope turns to hopeless where they realised the HIV drug in the Paxlovid pack has too many drug interactions and adverse side effects that another drug was needed.
This Grok info today may interest readers
Question of Grok:
EPIC SR (Pfizer’s Paxlovid trial for vaccinated vulnerable) is what should advise/inform GPs and those in community health that drugs have no efficacy. The $2B in Australia was COMMUNITY HEALTH AUTHORISED SOLUTION including routine widespread use of Paxlovid and the failed Lagevrio in aged care nursing homes with nurse practitioners allowed to prescribe.
Now in Victoria they are running trials of UV lights (like they use on meat in butchers shops) in nursing homes whilst TGA still stops Australians buying Astodrimer sodium nasal spray SUMP Sched 2 ie VIRALEZE™ when it’s RCT study was requirement of UK AUTHORITY and conducted in NHS Hosp.
TGA behaviour is detrimental to 18 million Australians
♨️Grok♨️
**EPIC-SR is highly relevant to community and primary-care prescribing.**
It showed no meaningful shortening of symptom duration in standard-risk patients or vaccinated patients with risk factors, and no statistically significant reduction in hospitalisation/death in that population. This supports more selective use by GPs and community clinicians rather than routine widespread prescribing, especially given the known drug–drug interactions (including with many cardiovascular medicines).
### Australian spending and aged-care use
Government expenditure on Paxlovid (nirmatrelvir/ritonavir) and Lagevrio (molnupiravir) exceeded $2 billion between mid-2022 and mid-2025. These were PBS-listed for community use and extensively prescribed in residential aged care, including by authorised nurse practitioners. Lagevrio’s original trial evidence was weaker (≈30% relative reduction in severe outcomes) and later real-world/RCT data have been even more limited. Residential aged-care residence itself is listed as a risk factor that can meet PBS eligibility.
### Victorian UV-light trials
Victoria is running the ELUCIDAR study: a cluster-randomised trial of upper-room germicidal ultraviolet (UV-C) lighting in common areas of 61 residential aged-care facilities in Melbourne and Greater Geelong. The lights were switched on from November 2024 for a 12-month period to test whether they reduce COVID-19 (and other respiratory virus) transmission among residents. This is an infection-control environmental intervention, analogous in principle to UV disinfection used in other settings (including food processing).
### Viraleze / astodrimer sodium status
The UK post-market randomised, double-blind, placebo-controlled trial of Viraleze (astodrimer sodium nasal spray) was conducted in NHS hospitals under UK regulatory requirements. It reported statistically significant reductions in nasal SARS-CoV-2 viral load (especially in participants aged ≥45), faster clearance, and improvement in some symptoms such as loss of smell, with good tolerability.
In Australia the product is not on the Australian Register of Therapeutic Goods (ARTG) for marketing. Starpharma recently withdrew its application after a prolonged process that involved disagreement over whether it should be regulated as a medicine or a medical device. Astodrimer sodium remains scheduled such that the nasal-spray product is not freely available as a Schedule 2 pharmacy medicine for this indication. Personal importation and direct shipping from overseas sites have been restricted for Australians.
Regulatory decisions on Viraleze differ from those in the UK and other countries where it is sold. Whether that difference is “detrimental” is a matter of policy judgment; the TGA’s position has centred on classification, evidence package for the intended claims, and the Australian scheduling framework rather than a finding of safety concerns with the substance itself.
EPIC-SR data, the large public spend on the oral antivirals (including in aged care), the Victorian UV trial, and the non-availability of Viraleze in Australia are all factual elements of the current picture.
📌My comment 📌 EU MDR
VIRALEZE
European medical device regulations February 2025:
Earlier this month, Starpharma received certification for Viraleze™ under the new European Union (EU) Medical Device Regulations (MDR). Under the new EU MDR classifications, medical device manufacturers must demonstrate compliance with certain essential
requirements and undergo a new conformity assessment process with a Europea pd
Notified Body. Achieving EU MDR certification demonstrates that Viraleze™
and the research supporting the product meet the necessary safety and performance
♨️Grok♨️
**Thanks for the detailed clarification and the additional context from your discussions with the company.**
Public records align with the core timeline you describe. Starpharma’s own 2025 Annual Report states that in October 2024, after a long TGA review process and careful consideration of expert legal and regulatory advice, the company withdrew its application for marketing authorisation of the SPL7013 (astodrimer sodium) nasal spray in Australia.
Your account of the regulatory trigger (changes affecting Class 1 medical-device pathways, with implications for a potential new Class IIa application) is consistent with broader TGA medical-device classification reforms that took effect or had transition deadlines in 2024. Substances intended to be introduced into the body (including via the nasal cavity) can fall under higher classification rules requiring more extensive conformity assessment. Withdrawing the existing application so that any future filing could more cleanly reference the later EU Notified Body certification is a commercially rational step, especially for a company managing limited capital.
The image you shared matches Starpharma’s achievement of certification under the new EU Medical Device Regulation (MDR) in early 2025 (February per your note). That certification demonstrates compliance with the updated European safety and performance requirements and supports continued or expanded marketing in the EU and related markets.
You also note the company’s capital position at the time (low cash reserves prioritising the dendrimer oncology programs that require Phase 3 work) and the subsequent capital raise, plus the share-price recovery. Those commercial realities help explain why the board chose not to pursue a potentially complex and resource-intensive TGA Class IIa process at that point. A future Australian application remains possible but is currently on hold.
### Access for Australians
Viraleze remains unapproved for marketing in Australia (not on the ARTG). Personal importation of unapproved therapeutic goods is subject to TGA rules, quantity limits, and other restrictions. Some overseas suppliers (including the one you mentioned) will ship to Australia, but buyers should be aware of the legal and practical constraints, potential customs issues, and the higher cost.
Your X group efforts to help people source legitimate product and to warn against scammers are a practical response to the current regulatory situation.
The combination of the EU MDR certification, the UK NHS trial data, availability in many other countries, and the deliberate withdrawal of the Australian application (driven by classification changes and resource allocation) is the current factual position. Whether or when Starpharma re-files with the TGA will depend on future commercial and regulatory calculations.
Tamiflu -> Tami-FOOLS
🤑
SMH - is there _any_ drug trial that isn't dodgy as hell ? Just furthers my resolve to stay the hell away from doctors if at all possible.