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I suspect the US regulators understand the potential broader uses of SNG001 outside of Covid, hence their willingness to make the protocol work at optimum level of efficiency, for want of a better term, to drive out not just Covid treatment data, but any other evidence that could help the 2million or so Americans who have asthma, and will still have asthma after this Pandemic is over, and will still be facing other virus-induced exacerbations in the future. Not all drugs on ACTIV will have that edge, therefore the protocol revision was wise.

Could broader clinical utility refer to the broader respiratory illnesses that SNG001 might have an effect on? I noticed that the Lead Investigator on the Sprinter US funding doc link that was posted yesterday (the one mentioning the 230+k$ cost), is listed as Monica Kraft. She is also the Deputy Director of A2DRC (short for 'Asthma/Airways Disease Research Centre'). That is the 'unit' that is undertaking the Sprinter trial (at least I assume so as it's on their funding sheet). That unit describe themselves in the following way "Our researchers are experts in the life sciences, clinical advancements, drug development and alternative therapies for the prevention and treatment of asthma, chronic obstructive pulmonary disease (COPD) and cystic fibrosis."

I mean it's not unusual that she or her department would be involved in atrial such as Sprinter, but I'm wondering if the "broader clinical utility" mentioned in the protocol is of special interest to their asthma, COPD and CF research. It would make sense, right?

Thank JoeyD Peelweight :-)

Thank you to those who raised and discussed this today - it's added clarity. I hadn't considered the implications yesterday.

It gets the drug under the noses of a lot of useful well-connected industry and trial people too. An added benefit when you look at the cost.

I mean the ones that replaced the ones that don't work. Oh wait....

Investowin, you can get the boxed LF tests sent direct to your home from NHS online. Available to everyone and free. You might find it easier than taking the kids to test sites and queuing. They send out the 'easier to use' ones now(nose only and not as vicious as the as previous ones, better for the kids). 30 min result. Just a thought in case you weren't aware.....

Investowin, you can get the boxed LF tests sent direct to your home from NHS online. Available to everyone and free. You might find it easier than taking the kids to test sites and queuing. They send out the 'easier to use' ones now(nose only and not as vicious as the as previous ones, better for the kids). 30 min result. Just a thought in case you weren't aware.....

Rumandpoker, I agree with you about releasing and publishing a draft. It's not done that way. To get a release drafted there would have to be a minimum review, which if you consider the interested parties names in the document, would have been a lot of very busy time-poor people. I can't see them officially reviewing a protocol that was just done 'on the off-chance Synairgen end up progressing'. That version wouldn't have been released, as you say it would be still parked on someone's hard drive. No doubt, it would be better to have absolute confirmation of that, but that's how I see it.

It looks very much like we are moving to P3?
Q: Is the protocol agreed with input /discussion with the company, i.e. Synairgen, or is it done independently from them?

I don't know about trialling CMWW2014.
Ref: Japan, Synairgen was granted a Japanese patent for the drug in 2011. If we get the green light, a future customer base perhaps?

Agree with you Peelweight. However, there was and is still merit in the home trialling. If you take the data out of it, P2 and A2P2 have been very valuable in the sense that they have tested the therapeutic strategy Synairgen seem to be persuing (hospital use) end-to-end. Prove that patients can take instruction remotely, prove it works for clinicians, prove ease of use outside of a hospital, etc. All very complementary information to have at hand for regulators when you may be expected to send patients home to continue use after discharge.

TLWilliams, on your first point I would say that the home trialling has been a firm proof of concept for that. It seems clearer now how they have approached this - whatever the home data, it's the proven remote technology/clinician/instructional element, plus the ease of use @ home element, that lend a greater case to our P3 trial. Those 2 proven elements can only complement P3 results. We are in effect testing it end-to-end.

Something tells me we needn't worry too much about PM.
If they are interested after positive P3 results, I'm sure there will be space for them in the queue.

Beautiful choir and orchestra Hold4results, never heard it before.

Whatever makes you happy AndyM, that's why we're all here. You play your own hand.
I hope it comes good for all of us.

Andym,
You post on the premise that the baddest actor would be our best and only choice. That Synairgen would receive no attention except for any crumbs thrown it's way by PM. That no other suitors would be in the game? How do you get to such a restrictive view of what might be?

“At my next hospital appointment I’ll be asking my consultant to switch,” said Edinburgh-based Olivia Fulton, 35, who suffers from severe asthma and has been using GlaxoSmithKline Plc’s Ellipta device that Vectura receives royalties for. “I do not want a tobacco company to profit from my ill health.”

It's interesting that it's not just Vectura but GSK (in this article example) that suffers the fallout too. Ultimately their shareholders were sold a pup on a reputationally damaging deal, and the backlash is but still in it's infancy. A cautionary tale if ever there was one.

Elsol,
It's a hard won argument. An arsonist selling fire damage insurance comes to mind. But this isn't about me or what I believe. If P3 results are good, rest assured that there will be pharmas interested in Synairgen's future fortunes. I don't know why PI's (or II's interested in reputational damage for that matter) contemplate a deal with a company best known for the toxic effects of it's products that caused the respiratory damage we seek to treat, WHEN, with good P3 data, Synairgen will have choice. It need not rush to the first suitor that flatters it, or indeed corners it. PM on the other hand must adapt or die, to put a fairly blunt spin on it. PM needs to rebrand to survive. There are plenty of big pharma pipelines that need filling, why would PM be any better than a Merck, an AZ or a GSK? Why would PM seem a more attractive suitor than them? I'm somewhat perplexed as to why an overture by PM would be considered good for shareholders when there could potentially be so many other (better perhaps?) options after P3?

The difference is Newcastle needs Saudi money.

Synairgen will never need Philip Morris and I suspect they know that.