Roundtable Discussion; The Future of Mineral Sands. Watch the video here.
Yes it’s from June. We have known the V7 protocol was written up for a long time but was blocked from release for regulatory/ approval reasons
I disagree with your assessment Ndn71.
I thought it was a great relaxed RM performance amongst some very highly esteemed speakers and think it was fantastic Synairgen got an invite to an illustrious event.
I also enjoyed both speakers who had very similar experiences with fund raising, dealing with government and regulators, both described manufacturing issues and had similar outlooks to Covid related topics. At times both men agreed with each other so I thought they were a great pairing.
I do find it a bit odd for an investor to think Synairgen shouldn't be an a discussion with some big players?
https://www.reuters.com/business/healthcare-pharmaceuticals/aurobindo-pharma-stop-molnupiravir-trial-moderate-covid-19-patients-2021-10-08/
Two Indian drugmakers have requested permission to end their late-stage trials on Merck & Co's (MRK.N) experimental antiviral drug molnupiravir in moderate COVID-19 patients.
The two Indian drugmakers, Aurobindo Pharma Ltd (ARBN.NS) and MSN Laboratories plan to continue late-stage trails of the drug for those with mild COVID-19, the Indian drug regulator's expert committee said on Friday.
The two companies separately sought permission to end trials in the case of moderate COVID-19 patients after having submitted interim clinical trial data around the effectiveness of the drug in treating this category of patients, the committee disclosed, throwing into question the efficacy of the experimental drug in improving outcomes for patients with moderate cases of COVID-19.
Separately, a senior source at India's drug regulator told Reuters that molnupiravir had shown no "significant efficacy" against moderate COVID-19 cases.
This was the Indian Trial inclusion criteria for a 'moderate' case
1. Male and/or female patients aged = 18 and = 60 years of age (both inclusive).
2. Patients and LAR willing to comply with study protocol requirements and voluntarily able to provide written informed consent.
3. Patients with positive for SARS-CoV-2 confirmed by RT-PCR in nasopharyngeal and/or oropharyngeal swabs within 5 days prior to randomization.
4. Patients with presence of clinical features of dyspnea and or hypoxia, fever, cough, including one of the following symptoms at the time of screening and randomization.
a. Respiratory rate = 24/min, breathlessness
b. SpO2: 90% to = 93% on room air
Im puzzled as to how much more 'mild' a case can you get? Why are the Indian generics companies stopping trials for futility?
img src="/static/846128eb6bfb4efcf4316c58d2aa64e9/002e951b49211421f8a823490f3d2e1b.svg" alt="illustration of person on ventilator" class="jss76"
I checked the website code and image info
Sadly its just their illustration of someone on a ventilator.
https://twitter.com/eh_den/status/1443971976586989570
I was going to do a bigger write up on Molnupiravir but this guys deep dive is far more in depth than I ever could, well worth a read (heavy science and long read). The safety profile of this drug has a dark past and the current safety data from Merck is well mercky.
Some easier reading from me -
https://www.science.org/news/2020/05/emails-offer-look-whistleblower-charges-cronyism-behind-potential-covid-19-drug
Controvesy when head of BARDA calls out the drug and previous companies abandoned the drug due to mutagenic effects.
Start of the pandemic Rick Bright (Head of BARDA) at the time warned of the dangers of EIDD-2801 (Molnupiravir) and refused to fund it. He was famously made to step down by the Trump administration shortly afterwards as head of BARDA after he refused to sanction EIDD-2801 without safety studies. Cast your minds back to ealry 2020 the Trump administration just wanted any drug and didn't care much for safety or even much proof of efficacy.
'Bright notes in his complaint that "similar experimental drugs in this class had been shown to cause reproductive toxicity in animals, and offspring from treated animals had been born without teeth and without parts of their skulls."
'Raymond Schinazi, an Emory University chemist who has extensively studied the active ingredient in EIDD-2801 but has no connection to DRIVE, notes that his former pharmaceutical company, Pharmasset, abandoned it in 2003 after discovering its mutagenic properties. Schinazi says the small chemical tweaks made to increase the ingredient's bioavailability and transform it into EIDD-2801 are unlikely to change its mutagenicity. "Thank goodness someone is raising the red flag," about EIDD-2801, Schinazi says. "You don't develop a drug that's mutagenic. Period."
***
More concerns from scientists on Molnupiravir and mutagenic effects
https://twitter.com/ChristosArgyrop/status/1444323202151313413
ß-d-N4-hydroxycytidine Inhibits SARS-CoV-2 Through Lethal Mutagenesis But Is Also Mutagenic To Mammalian Cells
https://twitter.com/BamBamBambrick/status/1444018163750948868
Not good - mutagenic in eukaryotes, ß-d-N4-hydroxycytidine Inhibits SARS-CoV-2 Through Lethal Mutagenesis But Is Also Mutagenic To Mammalian Cells
https://twitter.com/BallouxFrancois/status/1443993029174599682
While the efficacy of molnupiravir looks promising, we will need additional drugs. Its mechanism of action - it increases the mutation rate of the virus - might be relatively easy for the virus to develop resistance again. It could also lead to accelerated viral evolution, in particular at subclinical doses, which can happen for all sorts of reason, including when patients don't adhere to the treatment.
I thought it was common knowledge there would be a delay to P3 Sprinter with readout early 2022?
We shared the ISRCTN registry information updated by Synairgen a couple months back. This isnt unexpected news to the market just official confirmation to the masses.
These are the drugs on activ-2 - what we know
BRII-196 mAb - Already recruited for P3 and have an approval.
Eli Lilly Bamlanivimab mAb - EUA was revoked after a mutation escapes neutralization.
AZD7442 mAb - Other similar trials of the drug failed primary endpoint so suspect is its been dropped from activ-2 (tbc)
Camostat - Dropped from activ-2
Bristol Myers Squibb mAb - Under review.
SAB-185 pAb - Today were given $60 million grant to develop their drug from US govt so suggests they through :)
SNG001 - No news yet
So looks like the 3 drugs under review are Bristol Myers Squibb mAb / SAB-185 pAb / SNG001.
Re-read the sentence in the newspaper article you quoted its deliberately misleading. They can't fire anyone due to the legal issues so many are currently suspended or have resigned. End result is still a reduction in staff.
Officials who have blundered with the mandate don't believe a sizeable reduction of staff where the national guard has been drafted in is contributing to a crisis in care? Who are they kidding :)
Intentionally getting rid of staff that do crucial roles looking after people will have very negative consequences. If there is no one to feed people, adminster medication, lift people out of bed, make periodic checks on people with dementia to keep them safe etc
What do you think the end results will be?
Your the one who is witless if you can't see the outcomes.
Yes good idea get rid of the nursing home staff too in a sector that aleady has mass shortages of labour.
Think about it you are advocating letting residents die of neglect/malnutrition.
Idaho introduced vaccine mandates for health care staff and now find their hospitals short of staff as many have either been suspended or resigned.
The fact that these same nurses for 18 months were heros and with prior infection and repeat exposure to the virus will have superior aquired natural immunity makes the policy even more stupid.
A truly terrible policy that self inflicts staff shortages means likely collapse of health care system in many Western countries.
Could be the SNG team are in the USA to discuss Activ-2. 1pm is equivalent 8am US time.
Would be a nice surprise if SNG broadcast from the USA :)
That CDC study headline looks good on paper but I remember when it was released people picked holes in it. Reading the source study the authors even admit it has major flaws and cannot be used to infer causation.
The findings in this report are subject to at least five limitations.
First, reinfection was not confirmed through whole genome sequencing, which would be necessary to definitively prove that the reinfection was caused from a distinct virus relative to the first infection. Although in some cases the repeat positive test could be indicative of prolonged viral shedding or failure to clear the initial viral infection (9), given the time between initial and subsequent positive molecular tests among participants in this study, reinfection is the most likely explanation.
Second, persons who have been vaccinated are possibly less likely to get tested. Therefore, the association of reinfection and lack of vaccination might be overestimated.
Third, vaccine doses administered at federal or out-of-state sites are not typically entered in KYIR, so vaccination data are possibly missing for some persons in these analyses. In addition, inconsistencies in name and date of birth between KYIR and NEDSS might limit ability to match the two databases. Because case investigations include questions regarding vaccination, and KYIR might be updated during the case investigation process, vaccination data might be more likely to be missing for controls. Thus, the OR might be even more favorable for vaccination.
Fourth, although case-patients and controls were matched based on age, sex, and date of initial infection, other unknown confounders might be present.
Finally, this is a retrospective study design using data from a single state during a 2-month period; therefore, these findings cannot be used to infer causation.'
The problem with these stories is the assumption the vaccine would have prevented his hospitalisation. Thats just anti- science and for me the BBC having essentially an N=1 trial story is propaganda and scare mongering.
In multiple large trials people who had a prior infection of SARS-COV-2 were up to 40 times less likely to be reinfected than someone who had 2 shots of the Phizer vaccine.
Immunity from prior infection is real despite what MSM and Big Pharma want you to believe.
https://www.nature.com/articles/s41467-021-25509-3
We discussed this study yesterday on Reddit, more cool science.
This is a new study measuring autoantibodies in hospitalised Covid patients similar to Casanova/Bastard et al. In this study they used different arrays and found there are more autoantibodies caused by Covid-19.
The crucial part for SNG001 was this snippet. 'Interferons, particularly the Type I interferon IFN-a2, were targeted in multiple COVID patients at frequencies (n?=?23 across all interferons, 45%) higher than recently published findings from other groups.' As we know previous papers detected around 20% of patients with severe disease had type1 autoantibodies however this study found type 1 autoantibodies in 45% of people!
You need to zoom in a bit but this is a diagram of AABs detected - https://www.nature.com/articles/s41467-021-25509-3/figures/1 - Note how many seen for Interferon Beta.
Interesting as well are conclusions and questions they would like to ask in future
1) Are autoantibodies targeting traditional autoantigens or cytokines specific to COVID-19, or is their presence shared more broadly in patients with influenza and other severe acute illnesses?
2) Are autoantibodies found in convalescent serum used to treat patients with severe COVID-19?
3) Do any of these autoantibodies underly some of the signs and symptoms observed in “long COVID”, do they lead to classifiable autoimmune disease, and can they be used as predictive markers or identify subsets of patients who would benefit from targeted immunotherapies?
You can see clearly the thinking of the scientists with these new discoveries and the direction they want to go. There may well be further implications and clinical opportunities ahead. How amazing would it be if autoantibodies to type 1 interferon are similarily found in Flu, that could be a major win for SNG.
Good news for SNG as a main competitor is out the race and yes an unfortunate choice of logo.
Like mAbs treatments they are now focusing on the outpatient setting expecting drug to be more beneficial.
https://www.redhillbio.com/news/news-details/2021/RedHill-Biopharma-Reports-Top-Line-Data-from-Opaganib-Phase-23-Study-in-Severe-COVID-19-Patients/default.aspx
Arguably SNGs biggest competitor in the hospitalised inpatient space just failed the primary endpoint of its P3 trial.
From annual report - Expected to be fully funded for 2021.
Funding risk
The Group continues to consume cash resources. Until the Group generates positive net cash inflows from successful out-licensing transactions and commercialisation of its products, it remains dependent upon securing funding through the injection of equity capital. The Group may not be able to generate positive net cash flows in the future or attract such additional funding required on suitable terms, or at the time it is needed. In such circumstances, the Group’s programmes may be delayed or cancelled and the business operations curtailed. The Group seeks to reduce this risk through tight financial control, prioritising programmes which will generate the best returns, and keeping shareholders informed on
progress.
Going concern
The directors have prepared financial forecasts to estimate the likely cash requirements of the Group over the next twelve
months, given its stage of development and lack of recurring revenues. In preparing these financial forecasts, the directors
have made certain assumptions with regards to the timing and amount of future expenditure over which they have control. The directors have attempted to take a prudent view in preparing these forecasts, recognising the inherent variability in costs of the ongoing Phase III clinical trial of SNG001 in COVID-19 patients and the manufacturing scale-up activities. After due consideration of these forecasts and current cash resources, the directors consider that the Company and the Group have adequate financial resources to continue in operational existence for the foreseeable future (being a period of at least twelve months from the date of this report), and for this reason, the financial statements have been prepared on a going concern basis.
Recent AGM
Resolution was passed to raise further capital via a placing if required.
So end of September we will see interim report which will give us latest cash postion and outlook. We cannot rule out another placing as they may need another cash injection to get SNG001 over the line.
Here is the activ-2 website https://www.riseabovecovid.org/us/en/
As recruitment for P2 is complete he may not be able to participate with SNG001 sadly unless P3 progression has been confirmed. However there is a good chance a mAbs treatment could be available.
There are 2 sites based in Cleveland recruiting currently -
MetroHealth Medical Center
2500 Metrohealth Dr
Cleveland, OH
Case Western Reserve University
2061 Cornell Road
Cleveland, OH
Best wishes to your Father in Law.