Member Info for ChrisToffer

The low SP would be a concern to me if it was stagnating or dropping on the back of (results based) news but the only evidence we have to explain the drops are the TR1s by Acacia. Personally I find the speculative reasoning behind their selling to be sound (I.e theyre flipping shares in many AIM biotech stocks for a quick buck.)

I also think the market is no longer overpricing covid related shares based on speculation alone, like it was a month or 2 ago. It needs to see a bit more evidence of progression and what that means financially to the company.

In my mind this share is still way above where it would be if the pandemic didn't happen and still has stacks of potential to go further. But they have to deliver.

Apologies if this has been shared before but it gives a really good insight into the challenges they faced with the setup and recruitment of both trials.

https://www.nihr.ac.uk/documents/case-studies/urgent-public-health-research-synairgen/25079

Just reading this article on monthly prices of some interferon based treatments for MS in the US (Avonex/Betaseron/Rebif).

https://www.healthline.com/health-news/ms-why-are-ms-drug-prices-so-high-071913#2

If trial results are successful SNG001 will be well sought after at a premium.

CRL123, Regulations and due process are what keep people alive/out of prison. To abandon due diligence would undermine the 15 years hard work theyve put into the development thus far.

Yes at times of war (or in a pandemic) then the regulatory authorities (not SNG) have to look at ways of accelerating the usually slow processes they employ. Infact, SNG have went on record to praise the authorities for assisting in getting the hospital covid trial approved so quickly. They've also praised the authorities for their help in establishing the virtual home trial - which is breaking new ground just like you're suggesting they do.

They may be referring to recruitment being closed for the hospital part of the trial which was the prioritised trial by NIHR.

https://www.fiercepharma.com/marketing/gilead-prices-covid-19-drug-remdesivir-line-cost-analysis

Ive just been reading this article on Remdesivir. "In the NIH trial, the death rate in all patients—including mild, moderate and severe groups—was 7.1% for remdesivir compared with 11.9% for placebo"

The kind of revenue they are talking is astonishing!

One of the reasons the uptake will be slower for the home trial is because the inclusion criteria is made up of at-risk patients who are most likely being shielded, therefore less likely to come into contact with anyone who has the virus. It was always going to be a slow burner however SNG imitated in their annual report that it isn't necessarily a pre-requisite for the next step in the approval process. The hospital trial may be enough to start generating revenue (through millions of doses) by year end.

https://www.merckgroup.com/press-releases/2020/apr/en/Covid-19-Rebif-WHO-media-statement_EN.pdf

Merck statement on Rebif® (interferon beta-1a) donation to the World Health
Organization for the SOLIDARITY trial
As a company dedicated to human progress and to making a lasting difference on patients’ lives, Merck is
fully committed to contributing to solutions related to global health crises such as COVID-19.
As part of the global effort to investigate potential therapeutics for COVID-19 and our support of
independent research, Merck is donating 290,000 units of its interferon beta-1a (Rebif®) to the World
Health Organization for use in their global SOLIDARITY trial. The SOLIDARITY trial investigates several
potential therapeutics for the treatment of COVID-19 and currently has received expressions of interest
from over 70 countries. This complements our previously announced donation for the international
DISCOVERY trial sponsored by the French INSERM institute (Institut National de la Santé et de la Recherche
Médicale).
Rebif® (interferon beta-1a, solution for subcutaneous injection in pre-filled syringe) is indicated for the
treatment of relapsing multiple sclerosis. To date, Rebif® is not approved by any regulatory authority for
the treatment of COVID-19 or for use as an antiviral agent.
We continue to work closely with global and national health authorities to respond to the needs of
patients impacted by COVID-19.
For additional information on the DISCOVERY trial please visit https://presse.inserm.fr/en/launch-of-aeuropean-clinical-trial-against-covid-19/38737/; for more information on the SOLIDARITY trial please visit:
https://www.who.int/dg/speeches/detail/who-director-general-s-opening-remarks-at-the-mediabriefing-on-covid-19---18-march-2020
About Rebif®
Rebif® (interferon beta-1a) is a disease-modifying drug used to treat relapsing forms of multiple sclerosis (MS) and is similar to
the interferon beta protein produced by the human body. The efficacy of Rebif® in chronic progressive MS has not been
established. The exact mechanism is unknown.
Rebif®, which was approved in Europe in 1998 and in the US in 2002, is registered in more than 90 countries worldwide.
Rebif® can be administered with the RebiSmart® electronic auto-injection device (not approved in the US), or with the RebiDose®
single-use disposable pen, or the manual multidose injection pen RebiSlide™. Rebif® can also be administered with the
autoinjector Rebiject II® or by manual injection using ready-to-use pre-filled syringes. These injection devices are not approved in
all countries.
In January 2012, the European commission approved the extension of the indication of Rebif® in early multiple sclerosis.
Rebif® should be used with caution in patients with a history of depression, liver disease, thyroid abnormalities and seizures. Most
commonly reported side effects are flu-like symptoms, injection site disorders, elevation of liver enzymes and blood c

(Hit post too soon by accident there)

I was going to say that the secondary endpoints in that trial below were similar to some of our own and if the hospital trial of SNG001 can show similar benefits I think it would be viewed as very positive and may be enough to start the approval process.

I'm quietly confident on the hospital trial;

In this medical study that was posted a while back on the use of IFN-B1A the primary endpoint was different to our own trial however the 1Ahttps://www.medrxiv.org/content/10.1101/2020.05.28.20116467v1.

On day 14, 66.7% vs. 43.6% of patients in the IFN group and the control group were discharged, respectively (OR= 2.5; 95% CI: 1.05- 6.37). The 28-day overall mortality was significantly lower in the IFN then the control group (19% vs. 43.6% respectively, p= 0.015). Early administration significantly reduced mortality (OR=13.5; 95% CI: 1.5-118). Conclusion: Although did not change time to reach the clinical response, adding to the standard of care significantly increased discharge rate on day 14 and decreased 28-day mortality. Clinical Trial Registration ID #IRCT20100228003449N28.The hospital trial is testing

"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"

https://www.synairgen.com/wp-content/uploads/2020/06/19379_SY_AR_2019_v5-web.pdf

If you're an investor with a long term view (which i am), then they are due imminently. Even 3 weeks is nothing in the grand scheme of things (15 years development). I just felt that Algy's post needed to have that caveat added so we don't see a repeat ResultsAreLateGate.

Hi Algy, yes that logic and the standard industry turnaround times for readouts would suggest that COPD results are due anytime and may even be late. However, they were granted permission for interim analysis on the basis that the data would support the COVID hospital trial so they may be announced together. "Summer" is a big window.

Thanks Heid, and thank you for your ongoing contribution! That statement has been on the website for a few months now.

Gkb, DYOR and good luck to you!

Gkb, you call it inference, the rest of us call it common sense.

Out of interest, what do you imagine their update for the 'delay' would have looked like?

"We regret to inform you that people don't seem to be getting sick quickly enough to fulfil our earlier timeline of June for completion of the hospital trial, therefore it will now be July, which is still within the trial approval timeframe so doesnt require any further amendment, but we thought we'd let you know anyway"

Gkb, it is my inference (i would say its also SNGs) that trial completion and readout dates are driven by the recruitment of those trials so when they say "We have also been pleased with the progress of the SG016 trial in the hospital environment, having dosed 98 of 100 patients"; they see that as a positive, not a delay, because they have no control over how quickly patients get sick.

They did say earlier that they expected that it would be June however if you read the trial amendment around end of April it talks about how they couldn't get patients diagnosed quickly enough so were making the amendment.

These trials normally take years and some here are complaining about a difference if 1 to 2 months on a timeline.

Gkb, the reason for the 'delay' that you're looking for is stated in that RNS. Its always been driven by recruitment. The patients that are recruited have to meet a specific criteria therefore they need to be diagnosed early.

SNG has no control over the amount of people who get sick with covid and they can only fill the trial when they fill it. They don't need to explain that to me.

Nolupus, completely agree with you on the entry criteria. The point I was making was that they couldn't fill the recruitment quickly in the beginning as the turnaround times in testing/diagnosis were taking several days from patients being admitted to hospital.

The first amendment to the hospital trial addressed this with an improvement in the test kit they were using, which led to faster recruitment of patients who met the criteria.

That discipline by SNG resulted in the readout moving from June to July however it should hopefully also result in better data.

Takenorisk, the timeline is clearly laid out for those who are prepared to look and understand. June changed to July because of the 'slower' development of COVID testing.

I say 'slower' because development of covid testing/treatments are happening at an unprecedented pace. Still not quick enough for some it would seem.

Takenorrisk, the timelines are clearly laid out. We're looking at end of July with the possibility of COPD results earlier. What kind of update are you hoping for cause it would be immaterial until results are released.