Member Info for ChrisToffer

Hi Bryosa, you are correct in that the hospital and home trials are apart of the same trial approval. The company have not commented on the peer review process at all so it's likely that you are also correct and they are focused on talks with regulatory agencies.

Thanks everyone!

Yea I agree Big, the more i've read into it over the last day or so it seems that the peer review is only for the benefit of the scientific community, not the regulatory authorities or commercial partners. If you look at the link that Topupme shared below;

On peer review, "Publication in peer-reviewed scientific journals is currently the primary method for sharing clinical trial data with the scientific and medical communities, as well as the public (often through media coverage of published findings). These publications, however, contain only a small subset of the data collected, produced, and analyzed in the course of a trial"

On approvals; "Clinical trial sponsors seeking regulatory approval from authorities such as the U.S. Food and Administration (FDA) and the European Medicines Agency (EMA) must submit detailed clinical study reports (CSRs) and individual participant data, which form the basis for the marketing application for a product."

The authorities receive a much greater level of reporting detail and SNG have made it clear that their next step was to speak to those authorities. Because of this i'm not sure we'll see a peer review before we hear what is happening next with regards to achieving approvals. I'm happy to stand corrected btw because I think a peer review would only reinforce what we already know - this drug can be a huge help!

Hi San Diego, 10m doses would treat c715000 patients over a 14 day course. If this drug does what it says on the tin, do you think that'll be enough?

Additionally, £100 a dose to sng and/or a licencee isn't entirely unreasonable when you consider the NHS prices for Rebif etc start at £500.

I think AscottMatt was questioning the numbers (i.e 60 million vaccine doses) but if you think about it this way;
The current coronavirus cases are 17m, if governments were to buy SNG001 for treatment of 25% of that number at 14 doses each then that is 59.5 million doses.

Oh he's definitely that and even though i'm speculating on what comes next I have full trust in him and the team to do what's right, at the right time and in the right order.

I've no doubt that a peer review is required at some point it just doesn't appear to be high up in the company's list of priorities as they haven't addressed it in an RNS. I also completely agree that it'll be a formality because 'data is king' and all that. Therefore i'm not sure the peer review is a necessarily a pre-requisite to an expanded trial, or indeed a commercial deal. If it does come through before either of those events then all the better because it should strengthen SNG's hand (as will the COPD data).

The peer review is an interesting one because the company actually haven't commented on it or given any kind of timeline. They said that they need to finish the analysis and speak to the regulatory authorities about what happens next. Does a big pharma require a peer review to assess the potential value of SNG001. Wouldn't they have their own people assess the data?

Ascot, do you think large pharma companies are going to allow SNG to continue with the development of the drug (which will continue to drive up the eventual price) or look to tie in a deal ASAP with milestone payments etc?

With the pressure on governments worldwide to to have treatments in place ASAP, do you think the regulatory authorities will be looking for ways to fast track the next steps in the process?

That's twice you've shared that now Tombo under a different title. What's your game i wonder?

Sanofi is leading the clinical development and registration of the COVID-19 vaccine and expects a Phase 1/2 study to start in September, followed by a Phase 3 study by the end of 2020. If the data are positive, regulatory approval could be achieved by the first half of 2021.

As i responded to your previous post. We are at least 6 months ahead.

From the GSK RNS on this vaccine agreement this morning,

"Sanofi is leading the clinical development and registration of the COVID-19 vaccine and expects a Phase 1/2 study to start in September, followed by a Phase 3 study by the end of 2020. If the data are positive, regulatory approval could be achieved by the first half of 2021"

We are at least 6 months ahead of this.

Good morning all,

Thanks Yammyr1 for this link https://www.dailyecho.co.uk/news/18613675.southampton-led-sng001-trial-help-treatments-second-wave-hits/

It appears the rhetoric from Tom Wilnkinson (and to a lesser extent Eleanor Fish) is that the next step in development is to have an expanded trial in a country that is currently suffering from the virus.

One would assume that SNG will not be delivering that next step on their own so hopefully the commercial route will be clarified alongside the regulatory route to market.

Thanks Nolupus, that Faron patent would appear (at a glance) to also have a shelf life at 2-8 degrees for what they would prefer is 36 months. Maybe SNG001 doesnt have the advantage i thought!

i figure the Faron (traumakine?) Formulation is kept in lyophilized form until its needed in a hospital and then reconstituted for use.

Logically I would assume that SNG claim a shelf life of 36 months in lyophilized condition as well so my question then would be; in the home trial, do they reconstitute the formulation before sending the nebulizer out to patients and how long a shelf life does it have at that point?

The response to the questions around shelf life etc was also very positive. Looked like a clear advantage over other INF applications.

NewbieRookie, I'm not going to reply to the vax thread as its the 2nd thread you've started in the last 2 hours with title of a different product to ours. Makes me wonder about your motives.

What I will say is; look at the efficacy of viral vaccines that are out there and ask yourself is there still a market for a product like SNG001. Even with vaccine, people will still contract the virus and need therapeutics.

Sparkle what you're suggesting is highly unlikely. It would involve collusion from the BOD, Polar and VHCP. Additionally, the market would need to be informed if the BOD were involved.

Dyou not think the BOD are busy enough elsewhere at the minute?

So they sold up to 2.1million shares into that rise yesterday and the SP held the way it did? Thats pretty solid.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7188648/

This early paper suggested that INF Beta was more effective in treating Sars-Cov-2. There was also a report that INF Beta caused a positive feedback loop by promoting the expression of INF alpha.

Like Nolupus points out though, none of this has been demonstrated in proper clinical trials.

I found the stockpiling question interesting. First and foremost, SNG are concentrating on getting the drug approved and out there in order to help people, which is obviously the right thing to do. However any licencing discussions would have to consider how much governments would look to stockpile because that would inflate the numbers enormously.

Whatever you look at the numbers they look really high;

10% of the coronavirus cases to date treated with a £1000 treatment course would be £1.65bn