Member Info for ChrisToffer

Masqood7, any approval whether UK/US/International/Emergency will only follow when the trial has been carried out and SNG feel they have acquired enough data to gain approval. The process is a trial normal process. If the data shows the drug to be safe and that it help patients, then the conversation will be had with the appropriate governing authorities about whether the drug moves to stage 3 or gets a fast tracked approval (whatever that may look like).

It's interesting that Gilead has already signed 5 licencing agreements for the distribution of remdesivir following its' US emergency approval. https://www.proactiveinvestors.co.uk/companies/news/919607/gilead-sciences--remdesivir-to-be-distributed-in-127-countries-919607.html

The pathway is there for SNG001 and the trial is being carried out in the best manner possible for it to succeed but they've got to go through the motions, step-by-step.

Markets are a bloodbath today, only blues on my AIM watchlist are pharma stocks who have released positive RNS' and they've risen 20-30%. Shows what could happen here when news drops.

Fjones in the bin with ya! Waste of valuable oxygen you are!

The Roche reference isn't new news. Matt Hanc0ck mentioned them a couple of weeks ago in his briefing. The testing market remains huge and very much untapped. What company gets the bigger share may be debatable but any company that delivers a fast reliable test in a reasonable timeframe will make a lot of money.

Also, we know for a fact the drug is safe as it has been approved for home use. If it is proven to help - and there have been numerous reports posted on here that suggest Interferon will to some extent help; then we're looking at a clinically proven therapeutic for the treatment of a virus that has brought the world to a standstill. Try and put a price on that!

Nolupus, the irony of you suggesting that you may be the brunt of cynical comments is hilarious! All the facts that we have to go on are in the RNS' and the trial application/approval paperwork. If read and understood correctly then one can form an objective view on the potential of SNG. The general objective view here is positive based on that information, not selective hearing.

Yes KWA, there are a lot of level headed people on this BB who have been a massive help in my own decision making. Constant Pessimism and conversely, unfounded optimism should be taken with a pinch of salt.

Good morning KWA, there was a lot of excitement yesterday on what was a very good find on the US clinical website. Most of the excitement was due to mis-reading of that register and people mistaking it for a new trial. It is still a positive that the profile is being raised in the US. I would think the manner in which SNG are carrying out these trials would negate the need for further trials in the US. However the fact remains that we need positive trial results.

Nolubus does not get a hard time for stating the obvious. He clearly goes out of his way to be negative which suggests motive.

Hi ThisisFine, the RNS on the 30th April states 'The treatment of patients in the hospital setting in the SG016 study is progressing well, with more than 75 patients out of the target 100 now dosed with Synairgen's wholly-owned drug SNG001 or placebo. Results from this part of the study are still expected in June 2020. '

Hope this answers your question.

It's not a US clinical trial. I'm sure you can clearly see that as you were able to read it well enough to see both the primary and end trial dates earlier. After all, you quoted them in a post. Your negativity is depressing and so relentless that its no wonder people are saying you're a deramper.

It does appear that way JSP123. I take comfort from that because it's clear to me that SNG are conducting this trial in a manner that will gather the most amount of data under the best test conditions (double blind placebo in both hospitals and the home). Because of this, I think that if the drug proves to be effective and receives NIHR approval, the other approvals will follow very quickly!

What it does is reinforce the fact that if this trial is successful, SNG will seek US approval so they can commercialize the drug both here and in the states. That in itself is huge , however we already knew that. We still need successful trial results.

Safy, the initial trial application back in March quoted 400 patients. This US trial register is only a copy of the original trial application, albeit it provides more detail on the trial sites and the criteria. The RNS in April tells us that over 75 of the intended 100 hospital trial patients had been recruited. It then states, based on the amendment to the initial trial, that their intention is to expand the trial to 120 at risk patents in the home environment. The 400 patients originally quoted is most likely for contingency if they need to gather more data in different areas.

The registry of the trial in US may require an RNS, it may not. It is definitely good news however as the US have shown a tendency to approve drugs a little too easily and SNG appear to be doing a thorough job gathering enough data to pass the most stringent approvals.

The end dates will be a date that they believe is substantially far enough away should they need to expand on the trial. The COPD trial end date is also this year and its been running since 2018.

In the current climate with the amount of patients that will be available for trial there is no reason to discredit RM's previous guidance of June for results. That then opens up the opportunity for Emergency Use Approval and now with this register, US approval.

I think the're reserving their capacity for the RTC test. If it's government backed and linked to the tracing app then it'll be more commercially viable in my mind.

I don't find it confusing at all.

Mologic have contracted Omega to CE mark (now complete) and manufacture 46000 (per day?) ELISA tests at their Littleport facility. The commercial details of this is still to be released.
to be released.

Mologic and Biosure are developing tests that will be manufactured for and in Africa at cost price. Pretty obvious why ODX aren't involved, even if they had capacity.

Full link https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/884171/FINAL_6.6637_CO_HMG_C19_Recovery_FINAL_110520_v2_WEB__1_.pdf

Released today;

"The Government will increasingly augment swab-based antigen testing, which determines whether
a person currently has the virus, with antibody testing, which shows whether a person has
previously had it, once it is sufficiently reliable to do so."

It is only a matter of time here!

It is no different to Omega working with the RTC. Also mologic website states, "Mologic has taken the decision to sell the diagnostic test at cost to low-income settings to ensure affected countries have access to the kits during the global emergency."

There may simply be no commercial viability in this for Omega, they are answerable to shareholders.

Hi Dave, i've been having a further read and think i understand where we haven't been on the same page.

I believe when you refer to an antigen antibody test that you may be referring to the use of 'test antibodies' in the development of a POC antigen test. These 'test antibodies' would indeed be replaced by affirmers in the AVCT/Cytiva Antigen test strip. Both applications would be used to test a patient for the virus 'at that time' (antigen).

When i (and I think the others) have been talking about Antigen vs Antibody I have been talking about the specific testing of patients at the different stages of the virus. Antigen testing for the acute phase diagnosis (at the time) and Antibody testing for the presence of antibodies in the blood, post infection. These two tests are almost completely exclusive (See graph in the below link).

Ref:
https://thenativeantigencompany.com/why-we-need-antigen-and-antibody-tests-for-covid-19/