Member Info for Fruitsnveg

Or, it means they are poising themselves strategically for a bargain. Interesting days ahead.

Head of CMC (Chemistry, Manufacturing and Control).
Oddly fitting or tonight's discussion. Somehow I doubt he'll have left his old job to join a company with no immediate plans to upscale and manufacture product.

Doc,

I do think it's unreasonable to expect a company to mass produce anything before approval. That would be a colossal high-risk gamble. Shareholders would be furious if the company spent funds knocking out millions of doses prior to approval, but then returned unpalatable data. I can't imagine Institutions wouldn't go for mass manufacturing before approval either. They like contained risk. We have Warp Speed behind us, and the FDA have been updating their guidance on manufacturing for drug companies, the aim of both is to expedite.

You've ignored or overlooked the potentially far bigger non-Covid respiratory market for SNG001. The world has been waiting decades for a new effective drug to manage symptoms of COPD (for example) so if any delay were to happen, a few days, weeks or even months will not move the dial . The wider market for SNG001 will still be there.

You say "Failure to spend the money that was raised for trials and product manufacture will now lead to extra delays" but that's incorrect. Funds are being spent - costly trials are in progress and, as confirmed in last Q&A, a key manufacturing activity (validation of manufacturing process) is underway. Every thing on the critical path will have been carefully planned. It would be nice if 'manufacturing' were simply the more visible end product in boxes, but money needs to be spent on the less visible preliminary manufacturing and scale up activities too.

A final thought - I think our "competitors" are fewer than you fear - different drugs triallists are targeting different points of disease progression and the Pandemic looks far from over. It was never a case of First Past The Post Wins, that has long since been a false narrative. The FDA has always stressed they want a toolkit of therapeutics. Plural. Otherwise why spend all this time evaluating hundreds of drugs when they could have just just as easily thrown billions instead at mass producing the top 1 or 2 drugs? The answer is because they need more and better options (plural) for this pandemic and the next. They need a range of drugs.

Docdaneeka,
I think it's very unlikely that Synairgen wont have already booked slots with the likes of Aerogen, who have a very impressive, agile production system in place and are used to dealing with very tight timeframes that change. If you find an online interview (2020) with John Power, the CEO of Aerogen, he goes into detail about Covid- partnering and how agile plans and production have to be to meet needs of the Pandemic. Aerogen deals with many companies in our situation (awaiting a green light approval). It's worth a listen. Do you know how many nebulisers Aerogen can produce in a week in their facilities?

To add, I think it's inconceivable that any regulator would invest time and millions into putting a any company through trials if there was no proof of planning undertaken (by planning I mean a detailed roll out plan showing timescales involved in how they plan to meet delivery timescales, dummy 'slots' etc, all stacking up, with risks and issues for monitoring and managing to the nth degree). That plan would include manufacturing steps and would be a pre-requisite IMO.

Matterhorn,
Thank you for the mansplaining to me the pre-requisite steps (if it wasn't apparent, my ditty of 'If successful, all they have to do is shove some fuel in the tank and up, up we go.' was very much tongue in cheek). The point in case you missed it is that manufacturing (as opposed to approval steps and paperwork) should not be a problem because the company are already doing the necessary behind the scenes steps to ensure inhaled interferon "can be produced rapidly".
I'm sufficiently chilled about manufacturing.

I should have replied to Syn not you Doc, my apologies. Either way though, the slow meticulous grunt work will have been done by time trial ends and results known. If successful, all they have to do is shove some fuel in the tank and up, up we go. I can't see the manufacturing taking a long time, it should be as simple as flicking the 'Go' switch at 8am in production facilities. I'll caveat that by saying unless there is a worldwide shortage of components, but that will hit other drug companies too and will be beyond Synairgen's control...

Docdaneeka,

To clarify, regarding manufacturing, here's what the video said:
"The Synairgen team in Southampton is moving on to the next stage of delivering a study in the Community both in the UK and US and a much larger international phase 3 study in hospitalised patients. *The aim is to ensure that a million doses of inhaled interferon can be produced rapidly if these trials are similarly successful.*"
@ T3.46.

The company have already told is in the last Q&A that manufacturing process steps were being worked on, so combined with this latest MRC video, this looks good IMO.

Docdaneeka,
"A huge proportion of everything advanced by big -pharmas ( including both vaccines and therapeutics ) has been acquired or licensed or born from partnerships.".

You've somehow ruled out the 2 latter options as not being applicable to Synairgen - why is that? In my view licencing /partnering would eliminate both your concerns [your concern is that the company "will never really be able to bring SNG001 to market properly on its own - or protect it properly when the cheap copies start to appear on the market.] .

I would second that WelshFalcon, 100% my sentiments too.

I could well be wrong (I don't know the BOD), but I suspect and hope that they will stick to their baby like a limpet on a rock. If you've slogged away at something for 15+ years and actually see success, and are then assured of further success, you would probably be unlikely to walk away. Who know's though? Nice to muse all the same.

TLWilliams,

"I would prefer to see the company taken over if the long awaited outcomes of the clinical trials are as successful as the scientific evidence suggests. It is simply that the company is small, and thus far has had little support from any quarter. The resources of a major pharmaceutical company are desperately needed in order to make the treatment widely available to the masses in the shortest possible time"

IMO, Licencing (rather than TO) would also achieve this goal with equal if not more speed, and be the least cumbersome option considering timings involved. The fact that we may be sitting on a drug with reach far beyond Covid also makes it a less attractive handover to another pharma IMO. Rewards for 15 years high-risk slog should stay with the company and shareholders if that is what they prefer. Assuming a successful P3, I see no issues raising cash in the future or market leverage. We know that is the BODs preferred route and something RM has been working on - perhaps we will learn more when the time is right and trial results are in? I do hope so.

I agree, they are confident.

GGG21,
The MRCs say their mission is to
"• Advance and disseminate knowledge and technology to improve the quality of
life and economic competitiveness of the UK
• Promote dialogue with the public about medical research"

They are putting money behind Synairgen as the subject of this vid, ticking both those boxes. This is a youtube showcase. They could have chosen many other drugs to showcase but they chose the Synairgen story. That tells me they are convinced of the science they have helped fund and the long term potential of SNG001.

Apologies, I meant Sept 2021, not Sept 2020! My bad. It is far more recent than I thought - which is even better IMO because it will be based on very latest info. I see this as a very strong indication of the MRC's support for this company, no small thing.

This an interesting video produced by the MRC (Medical Research Council) focussed on Synairgen, albeit back in Sept 2020 but for me the fact that they produced this then and it's message shows the very strong faith they have in the drug and the science behind the inhaled delivery method. For those who never heard of them, the MRC invest in research on behalf of the UK tax payer. Amongst many facts & figs, "MRC research is linked to the formation of 77 spinout companies bringing discoveries to the market".

I have not seen this vid before so thanks to those who posted - it is worth watching to understand the some of the backing that this behind getting this drug to market.

https://www.pharmacytimes.com/view/newest-covid-19-surge-leads-to-shortages-in-therapeutics

Good start. Now look at their litigation history. FT. WSJ. Etc. Go back a few years. Aggressive is a good description. Friendly? I don’t know yet.

gggg21, I'm as intrigued as you are, I'm sure more than a few of us are. Interesting days ahead. GL.

“With the Delta variant, we’re seeing very fleeting contact leading to transmission,” Young said.
At the start of this pandemic, I spoke about 15 minutes of close contact being a concern. Now it looks like it’s five to 10 seconds that’s a concern. The risk is so much higher now than it was only a year ago.”

https://www.theguardian.com/australia-news/2021/jun/24/its-in-the-air-you-breathe-what-you-need-to-know-about-sydneys-delta-covid-variant

You said it Doc.
Sorry for your loss Mact4.