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Positive position no doubt. 10% holding. Realistic about risk. Interesting to hear their outlook. Well done to all the question placers as we were first to get addressed due to the volume of them.
Why the 10% holiding?
Gareth Powell (board member) said
"mid stage data looks very good" "hopeful for data being positive for COVID patients" "and if it does work it will raise the potential for the drug to be used in other areas as well"
" a typical kind of small cap biotech with a lot of upside if things work out but also obviously downside risk. So I'd class it as high risk"
Assuming it’s us, we are one of 3meds in a very well funded US trial, ACTIV_BRII starting in the next “week or two”. My money is on that for speed of recruitment. Massive
And respect to Dafad, PMJH and all the teamwork in rooting this out
Top effort Dafad
This is the biggest news of a big morning!!!
Credit to the Syn team for getting started and coordinating BBC 7am news coverage on day of RNS. Here we go!!
Good bit
“several UK sites have now been initiated, with further sites in the US and the EU expected to follow.”
Great that they have got “several”going. And more will likely quickly follow.
But what has made them say-
“We believe this trial presents an opportunity for a significant UK scientific breakthrough and, if given the right support, our drug could rapidly assist with the global crisis.” I worry why they have felt the need to put the last bit in!?
Reporting first dose on now
In the air tonight-
Can’t wait for the drums to kick in at 3m34s!!
Maybe a 5pm RNS ??
FayeConnie, it isn't critical for sterility. Just clean, like an inhaler for asthma or a tablet. Not sterile like a medicine to be infused into a vein. Simple system to load if needed.
OK, thanks everybody. Fantastic effort. As promised the big reveal!
Synterferon 13 "recommends"
Also close
No more Tiers 12
I can’t believe it’s not MAB 9 (Monoclonal AntiBody)
"Yearnings" anagram of Synairgen
Def " A feeling of intense longing for something/ someone" (RNS perhaps ;)) 9
Puff ’N Go 7
Imminentairgen 7
Marden's Magical Mist 7
Notable others include
Holgateron 3
BOJOS Mojo 3
Top effort. Sorry to hijack the board all day!!
Synterferon still has it!
Let’s hope they have been saving SNG001 for the big Brexit reveal for the new agency!
Synclear C5
Viralyse?
Should have said we can use recommendations as a voting system. Winner announced 10pm
Let’s assume RM reads the board and try and help his marketing team. SNG001 needs a better trade name
Suggestions please?!
I agree that is why so many countries listed. Some will have too few cases, some too many - just overwhelmed. Some hospitals/countries will be able though. Then they have to be up for “selling” this RCT over other ones as each patient will be enrolled in one study.
Game changer. Great news for the world. This can be delivered at scale and huge stockpile available.
Not been looked at yet but FDA have added an analysis of long COVID to P3 as of today. It will not slow EUA for main non-long-COVID indications and result will come later but still good to know. IMO
Pros
P3 will take 67% of the time to complete -great for us and FDA/world population
Cons
Slightly less likely to hit the sweet spot of dosing to create a global superstar drug. So if 70% chance of P3 replicating P2 results with original protocol, in my view this is trimmed a shade with the change
Noted Matterhorn, though remember that ethics applications and approvals are a moving feast. See SG016. Started out as an in-hospital P2 trial. That has reported in the Lancet but it is the vehicle that is doing the home testing patients still (as an add-on).
The main P3 ethics is granted without home trial with the following as three of the inclusion criteria
2. Admitted to hospital due to the severity of their COVID-19.
3. Positive virus test for SARS-CoV-2 using a validated molecular assay (e.g. RT-PCR). Patients who had positive virus test for SARS-CoV-2 prior to hospitalisation will be randomised no later than 48 hours after hospital admission. If the virus test was performed more than 96 hours prior to hospitalisation, the test will have to be repeated in the hospital prior to randomisation. Only patients whose repeated virus test is positive will be randomised, no later than 48 hours after confirmation of SARS-CoV-2 infection. Patients who had positive virus test for SARS-CoV-2 after hospitalisation will be randomised no later than 48 hours after confirmation of SARS-CoV-2 infection.
4. Require oxygen therapy via nasal prongs or mask (OSCI score of 4).
However it is plausible that that same vehicle (SG018) can morph to include other elements via the same ethics committee, should the FDA wish it to have a home-trial supported by Warp-Speed, if Synairgen wish to. Or they could start another P3 application. I think the latter is highly unlikely, the least number of RCTs set up the cheaper and faster it is. IMHO
CW
Thanks for updating us. Really appreciated and just great news!