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I think the activation of this agent means the starting to dose SNG001 in the Phase 3 of the trial.
The reference to Omicron could mean several things.
1. They are looking at the endpoints of the trial because of the reduction of deaths or serious illness in the participants means all trials could fail endpoints. (Due to SOC and the Omicron effect)
2. They are considering delaying the trials to examine the cost effectiveness of the trials in the current form.
I am hoping it is (1) above.
If Synairgen started mass production without Phase 3 results the Company would now be bankrupt and facing disaster. They are managing their resources carefully. They still have £25M in the bank.
I think they are manufacturing only the quantities required for trials.
The new drug announced today as a successful treatment for covid only reduces the risk of death or serious ilness by only 20%. This was tested as part of the Recovery Trial.
Our unsuccessful drug SNG001 however cuts this risk by 10-20% more at 40%. Where is the justice?
More details here.
https://www.bbc.co.uk/news/health-60601750
The pause is for " Due to the need to modify the study design". They are reconsidering the endpoints and the placebov SOC etc.
You will see a revised protocol before progressing to phase 3. The supply of the drug is paused until then.
Thanks for the link.
Their past record and mangement style seem to suggest that they will try and dictate terms where possible.
I am hoping that they will increase their share and influence the outcome to the benefit of us all investors.
I am thinking about how this will pan out over the next 12 months.
1. It is possible Polygon will buy up to 29% and leave it for the next 12 months awaiting Active trial data. The share price may hover around current levels until then. This gives them the opportunity to offer a deal to other shareholders lower than what they have to do now ( £2 or more) under current regulations.
2. They may be buying on behalf of someone very keen to buy now and control the affairs of the company more effectively to make sure the next trial will be successful
Any thoughts?
One of the reasons why the Phase 2 of the Active trial was slow to progress was the limited availability of the drug. It was only available at limited locations. therefore the recruitment was slow.
Perhaps now Synairgen would take quick action to make the drug available for the Active 2 trial in sufficient quantities to speed up the progress. Is it not the single most important task they shoul concentrate on given what has now happened?
The comparison tables in the RNS clearly shows (SNG+SOC) v (Placebo + SOC).
Therefore SOC was applied to both groups. Te question is what is defined as SOC and did it include steroids or other medication which would influence the outcome?
We do not know at this stage.
My thoughts are now where to next?
Synairgen clearly do not have sufficient funds to do another trial.
They can run the company for several years with the available cash to support the Active trial.
If they can prove that the Sprinter Trial was flawed then they may be able to persuade a big player to take a chance on another trial.
If all these fail then the future is uncertain.
I am waiting patiently to hear a post mortem from Synairgen to decide what to do.
The study protocol does not mention state of care. It is a double blinded study and therefore if steroid treatment was used it has to be adminitered to both placebo and the SNG patient equally.
I am still struggling to undertand the SOC element RM is refering to. Alternatively was the protocol not followed by the institutions involeved in the study? We need some clarification surely?
Is the active 2 study a better controlled study?
Thanks for the link.
I still think if we selected 25 candidates at random from our own trial and interviewed them in such detail it would have been more representative of the accuracy of the results.
This looks like a new request from authorities or an ommission from our original tial.
Why interview 25 new participants for up to 2 hours with a set of detailed questions with detailed scoring system to evaluate the validity of the 2 questions included in our SG018 trial? What would you gain from this?
It is not clear if these participants have had any other forms of medication which may skew the answers.
Why not revisit 25 SG018 participants and ask these questions for comparison?
It looks that way indeed.
Therefore you have to take this before you can even make an appointment with your GP ( Average waiting time can be a week or more) and before you can receive the results of a PCR test.
You have to keep a DIY testing kit at home and persuade your GP to prescribe the pills on this basis?