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HSD,
Yup. That’s how clinical trials usually work.The patient’s under supervision.
How else will you prove superiority to the ‘competition’(SOC) - bearing in mind this is a Phase III - if you simply add one on top of the other? It makes no sense.
A Phase III in asthma would never involve adding say, a novel bronchodilator in top of SOC salbutamol or budesonide. The results would be meaningless.
Hi Tommy, to be fair to Blue he did submit a few questions and they were asked and answered in a lot more detail than we put in the summary - it's a shame because they did give some really comprehensive answers ref SPRINTER, SOC, End Points etc but as you can imagine it was very difficult to write down every point made.
I would agree with you that a nicely worded E-mail to Synairgen is likely to get a detailed response.
This is exceptional work, Doc83 and Wigster77. Thank you!
Blue
We’ve found the company to be quite open to discussion and you clearly understand the science at a far higher level than I and many on this board.
I’d be surprised if there was a test they’d missed that could have shown them their drug doesn’t work and they were wasting everyone’s time but It would probably be useful for you to email either Philip Monk or Brooke Clarke at Synairgen with your question. They really are open to all questions,
It’s a shame you didn’t raise it earlier as I’d have been happy to pass it on to those attending from this or other groups
ATB
I m not sure I’d describe 70% reduction in severity amongst a 3rd of the trial as a dud.
But we each have our own views on what is a highly complex disease that even now few fully understand.
ATB
Very kind offer Manifesto!! Yes, would be great for a few of us to meet at Big Jonnys at some point when the SP is considerably higher and put a bit of cash into his tills :-)
Tommy - on When asking the question why didn’t they think about the impact of SOC I think you also need to ask what you expect them to have done about it?
If the metabolic pathway suggested that interferon would fail the trial under SOC, I would have expected them not to go ahead with it and establish a fail but to rethink the trial & perhaps say that developments in SOC have undermined the effectiveness of interferon. Instead, we wasted all that time waiting for a dud when perhaps experts in the field had an inling/could guess/knew what was coming. What was the advantage in going ahead? We know they are enthusiastic about long Covid, COPD & other uses, what is the benefit of that sophisicated a trial nullified by a clash that may have been anticipated in its metabolic biochemistry?
Big Jonnys buy out party I hope
Sending a virtual IOU to all posters who kindly shared their
thoughts from the AGM for a few Beers.... Huge thanks for
your time and generosity to other shareholders... Hope
to see you at the next AGM and a few other regulars on here..ATB!
M.
wetdream - "when I see no mention of SOC I take it we’re up against placebo - which is what’s stated in this version of SNG018"
So you thought some of these hospitalized patients would be given nothing but a placebo and told to keep their fingers crossed?
Big thanks to Wigster and Doc. Son much of interest said. We will have our day. I did find the EUA q&a very interesting also. EUA not ruled out if a very dangerous new variant. “Unlikely” though they did say.
A bit late in adding thanks, but have just read every word on way home after 6 flights in 7 days and well knackered, but full of excitement, and admiration for fellow PI's who have put the summary together. I feel you may have just done another service by hopefully galvanising our band of SNG'r's despite the wide and varying views often expressed. I will certainly sleep well and may even try to summarise to Mrs A !
S/b SG018
TommyD_19,
Yup, I get your point. Thanks.
HSD,
I understand the basics of clinical trials.
The protocols are usually airtight, so when I see no mention of SOC I take it we’re up against placebo - which is what’s stated in this version of SNG018:
https://www.isrctn.com/ISRCTN85436698
What interests me is when (and why) any change was made. And why Marsden et al were so surprised to see just what SOC was comprised of(what were Parexel up to)?
Mulling over our superb shared reports from Posters here at the AGM..
My take is we still intend to go it alone for Covid....But are still
looking at outside opportunities to collaborate on COPD/ASTHMA.. ( Throwing darts..) ??
It’s also worth noting there is no such thing as Standard of Care as you might think of it.
Standard of Care is a guideline interpreted by clinical
Physicians and will vary from region to region, across continents and according to clinical diagnosis of the individual patient and drugs available.
So in one hospital you might get Dexamethesone, in another or on another continent you might Remdesivir or you might get both or any number of variations
wetdream - "What puzzles me is why there’s no mention of SOC in the US trial protocol."
Probably for the same reason they didn't explain that the weird symbol at the end of 50% is a percent sign, and it means 'out of every hundred'.
It's up to us to understand at least the basics of clinical trials, and realizing that they're not going to deny patients the best proven care just to trial an unproven drug is part of that. It would clearly be unethical.
This is from a downloaded copy I have
Protocol: SG018 IMP: SNG001 – IFN-ß1a nebuliser solution Version 3, 21 December 2020
4 STUDY MEDICATION
4.1 Allocation to Study Medication
Patients will be randomised to one of two groups (SNG001 or placebo) in a 1:1 ratio to receive SNG001 (two syringes [Arm 1]), or placebo (two syringes [Arm 2]), according to a pre- specified randomisation schedule in addition to Standard of Care (SOC).
I downloaded my copy from an Italian trial site
Search sg018
Download the zip file and one of the 3 files inside
Is the English version
https://www.aifa.gov.it/ricerca-aifa?searchKeywords=Sg018
Thanks.
Can you give me a link please - not to the results, but the protocol issued to hospitals?
TIA
The sprinter trial protocol is the main source and covers the entire protocol in depth and it’s clearly stated in that document. Clinicaltrial gov is only an overview
What puzzles me is why there’s no mention of SOC in the US trial protocol.
https://clinicaltrials.gov/ct2/show/NCT04732949
Anyone got any suggestions?
Whilst we enjoy Sir Holgate’s excitement about long covid. I thought it worth reposting something I posted a few months back. This was a round table discussion between the FDA, two leading BP. Astra Zeneca and Novartis and amongst others RM representing Synairgen.
https://www.parexel.com/company/long-covid-19/roundtable
https://www.parexel.com/application/files/6816/3483/6442/17_PE1121_Brand_Insights_Parexel_RePrint94.pdf
When asking the question why didn’t they think about the impact of SOC I think you also need to ask what you expect them to have done about it?
No hospital would have or will trial our drug and deny SOC to a patient. Knowing or not knowing makes little difference. Our drug has to show benefit over and above the best alternatives. It does that but statistically needs a much larger trial to demonstrate the significance for commercialisation but that will come from a PT.
Synairgen simply do not have and never had the funds to complete a trial of that magnitude on their own
Thanks to everyone over this week for the positive conversations, hard work and detailed insights into the AGM.
I have a really good feeling that this could be the start of a positive 12no the ahead. Hoping this SP is the bottom and news of trial inclusions and positive activ 2 data will start sending this back in the right direction.
Really sad start to the year but with that behind us I am optimistic for an exciting 2nd half to 2022. Clocking off now until future news so once again thanks to all AGM attendee contributors and manifesto for months of keeping the faith I’m sure many are grateful for your contributions.