Member Info for ChrisToffer

Good morning Nolupus, certainly haven't forgotten that both the at home and hospital sections of the trial are part of the one trial and until the release of the annual report I was under the impression that both would be required to start the approval process. However (and apologies for repeating myself to the others), the report says, "Data from the hospital trial
will read out during the summer, and, if positive, the Company will work closely with regulators to determine an expeditious route to securing approval for SNG001"

The risks still remain whereby the hospital part of the trial would still have to deliver positive results however that statement would suggest that the home part of the trial would not necessarily need to be completed ahead of the approval process starting. Would you agree?

Yea i suspect you're right. A combination of them making sure patients met the entry requirements (72 hour since Infection), coupled with the delay in adequate testing times may have resulted in the delay in recruitment. If that is the case then it was a very disciplined and professional approach under immense pressure to 'just fill up the numbers.

I'm not so sure Crookie. I was of the opinion about 2 weeks ago that the the hospital may not show the levels of improvement to get this over the line on its own however the report posted here last week on interferon 1B through IV showed an improvement of c.20% in hospital patients (14 day discharge and 28 day mortality rates). Coupled with the way SNG meticulously took their time in hospital trial enrollment, I'm feeling a lot more confident. If the hospital data is good then the home trial may be a bit of a slow burner whilst the drug gets approved.

"Data from the hospital trial will read out during the summer, and, if positive, the Company will work closely with regulators to determine an expeditious route to securing approval for SNG001"

They may not need to wait for the 3rd result (home trial) to crack on with approvals.

I agree Ghia. The manner in which the company continue to conduct themselves in a market that is dominated by those who shout loudest just oozes confidence. Although they quite rightly highlight the risks, the other data that has been posted here (thank you all!) about the benefit of interferons is a huge de-risking factor for me.

That annual report is fantastic! Love the company outlook

"Data from the hospital trial will read out during the summer, and, if positive, the Company will work closely with regulators to determine an expeditious route to securing approval for SNG001, a treatment we believe could play an important role in addressing the current COVID-19 crisis and similar viruses in the future. In parallel the Company is now working with manufacturers to scale up for potential demand for SNG001. The outlook for the business is positive and we look forward to updating the market on further progress in due course."

It does also highlight the risks involved (that the drug does not work) as well as showing the commercial aim,

"Our customers are the large pharmaceutical
and biotech companies who have the resources
and infrastructure to take our products to
market. It is therefore critical that we interact
with these companies at an early stage to make
sure we are developing a product which they
may wish to license."

I honestly think it is that approach that is behind the uninding of the COPD trial data. Very reassuring report.

Hi Nolupus, If another round of fundraising is to be carried out to support P3 trials/production and that is having an effect on the current share price, are they not obliged to inform the market? Do they (like the rest of us) not need to wait on all of the results being unblinded before they can make that decision?

Also, IF Sinairgen are to go through another round of fundraising to aid further development, surely that means they are self funding the later development stages which would A) mean the drug works to some extent (success) and B) will be worth more when they eventually entering licencing/distribution negotiations (double success).

The only thing that is astonishing is that you spent all that time writing a post that contributed nothing.

DubleD - if your gains are covering losses elsewhere then why did you re-post last weeks speeding ticket earlier? Surely if you're not that confident in what you've invested in you would not want to put the brakes on a rise?

It is being trialed as a standalone so we will soon find out how it performs on its own against COVID & COPD. To expand on what the professor was saying, the fact that SNG001 could/should be coupled with an specific antiviral to combat a specific virus (in this instance, COVID) actually points towards a far more generic use of the drug which is surely more marketable?

I agree we've not learned anything new however the interview was posted last week and that clinical trial was posted on Saturday so what we are continuing to see is the same narrative (supported by science and scientists) that this drug can help fight this virus (among others). There hasn't been any substantial counter argument (backed by science or scientists). What remains is for it to be scientifically proven through clinical trial i.e peer reviewed and approved by the appropriate governing authorities to allow mass production.

Me too! i'm trying to get the timing right with a riser that i have a holding in!

That interview is fantastic. Calm, considered and concise. Thanks Sharesting.

Mike29, if you read the link posted this morning on another trial of Interferon 1B administered by IV it showed benefit on discharge (14 days) and Mortality (28 days) rates.
https://www.medrxiv.org/content/10.1101/2020.05.28.20116467v1

Anyone that's invested in shares and hasn't got a plan on how best to handle the tax on their profits, really hasn't thought it through much.

Thanks Nolupus, just been having a read on the guidance for initiating trials and yes can see that is where the dosing would be decided. Do you know; would an assessment of different dosing levels be seen as a re-start of phase 1a-1b or would it be assessed as a delta to the original trials?

Also, i've just read that as local delivery increases drug concentration at the target site, dosage levels with an IV would probably be more than in an inhaled application anyway.

A lot of speculative talk on here so giving this post by Chantico this morning a bump.

"Interesting article in medRxiv on Thursday reporting on a trial using injected Interferon beta (IFN).

medRxiv is a medical archive that publishes preprints of medical research before peer review.

SNG's nebulized treatment should have higher efficacy than injected treatments.

Conclusion was this:

The 28-day overall mortality was significantly lower in the IFN then the control group (19% vs. 43.6% respectively)

.....significantly increased discharge rate on day 14 and decreased 28-day mortality

Bottom line - IFN works for significantly improved outcomes.

Report is here https://www.medrxiv.org/content/10.1101/2020.05.28.20116467v1

Can dosing levels be adjusted for phase 3 trials? I was under the impression that one of the aims of the broader phase 3 trial would be to hone that type of thing.

Hi Nolupus, in that link that you posted they say, “The concept that’s emerging is that this is not a respiratory illness alone, this is a respiratory illness to start with, but it is actually a vascular illness that kills people through its involvement of the vasculature,”

The administration of interferons by IV may indeed help a vascular illness (IF their theory on COVID is proven to be correct), however they are in agreement that it begins in the lungs therefore reinforcing the argument that nebulized treatment into the lungs early in the illness would also have significant benefit. I don't see that link as a counter argument to the nebulised method of treatment.

Fantastic stuff! I was thinking the home based trials would show the greatest benefit and that anything positive out of the hospital setting would be a bonus. That report suggests we may see very positive results from the hospital setting. I actually think the 66% to 43% discharge on day 14 is also very positive. If that were scaled up it is 20% less strain on health services.

DubleD, you are aware that that is the whole point of companies subscribing to a share placing?

They did contest it Imac. Someone posted an email response from Omega yesterday where they said they felt the situation did not need clarifying.