The latest Investing Matters Podcast with Jean Roche, Co-Manager of Schroder UK Mid Cap Investment Trust has just been released. Listen here.
Last patient(s) will have their 35 day assessment by/on 14 December. Right now, all of the analysis protocols will be sitting ready to run. 95+% of patient data will have been entered into data base.
In the light of current developments, I think that a preliminary top-line readout during the 11 remaining work- days between 14 and 31 December is not only desirable but feasible. Particularly so if the results are clear-cut, as many of us expect them to be.
The way these conferences and panel discussions are publicised usually involves a request to speakers to submit a mini cv AND A MUG-SHOT. RM’s photo here, taken together with the yellow plastic water bottle photo on the blurb for the 6 October event lead me wonder what kind of non-verbal message hr is trying to put across. Pretty up-beat, verging on the ebullient, I would suggest!
So, on 6 October, RM could talk about a 2021 readout. That was after the summer slowdown in cases and recruitment to SG 018. I think we must be a little bit off that pace now as the best they can do IMO is 8 weeks from LPD to high level results. This would take us to 4 January, even if we got a LPD tomorrow. And that’s assuming that Christmas is cancelled for Synairgen and their number cruncher contractors. But unless there has been a further dip in recruitment in the last 4 weeks we must be very close to LPD with the prospect of a high level readout early in January.
“jolly hocky sticks and cream teas etc” …Fruits, I laughed out loud! But I agree with everything you say. This was just about the most insightful discussion I think I have heard on SARS Cov 2 and it was a privilege to hear these top scientists voicing so many of the views that have been expressed here long since - vaccine obsession, mega-trials on rubbish prospects hoovering up subjects and slowing real possibilities, political shenanigans, etc
I think that the bit of the process that will take least time is the data “crunching”. The crunching machine will be well in place by now in the sense that the data bae, spreadsheets and templates will have been constructed long since and, in the case of the DB, will have been populated with data from the field on an ongoing basis. This will have allowed the interim analysis after 300 patients.
Once the final verified data is uploaded, someone will press the “return” key and the “crunching” will commence and, to exaggerate a little be done in a heartbeat.
The time consuming bits will be the prior data cleaning and the checking, review and setting up of secondary level analyses, dependent on the primary analysis.
The turnaround time for SG016 was 7 weeks from last patient recruited to announcement of high level results in the RNS of 20 July last year. Add a week for the 35 day duration of the study (not counting the 90 day visit) and we could expect an announcement 8 weeks after last patient recruited.- festive season permitting
Scepticism is all well and good in self-actualising people who feel well going about their day to day activities. But, when the realities of infection and of clinical deterioration kick in, any notion of immortality evaporates pretty quickly and the wish for an effective therapeutic to alleviate breathlessness and other manifestations of respiratory distress kicks in pdq. Maslow’s hierarchy of needs in action.
Fruits ..yes, if it is possible to take a detached view of the pandemic, I have found it fascinating. The explosive rate at which the science around the virus, vaccines and possible therapeutic approaches to its treatment is mind blowing to an old codger like me.
Synairgen were right in the zone when the pandemic started and, taking account of the size of the company, have made remarkable progress since. People who complain about the “delays“ in the completion of SG018 just don’t understand the enormity of the task and the years that such a study would normally take to complete; a delay of a very few weeks Is almost an irrelevance.
There is nothing that I have read about the nature of the virus, it’s mode of action, the importance of interferons and, more recently, the role of auto antibodies that makes me less than wholly convinced of of the argument that “it (i.e. SNG001) works”.
We have a lot to thank contributors and commentators - here and elsewhere - like WedME, pmjh, Casanova and even our old friend Dr Mary for.
We are approaching the end-game now. The next few weeks are going to be exciting – hopefully in a good way - not only for those of us invested in Synairgen but also for the patients who stand to benefit from a truly transformational therapeutic.
I thought it was a bit of irresponsible journalism from a usually excellent Nick Robinson. Not a health journalist, though. The BBC health pros would not have touched that with z barge pole.
SG016 announced last recruit dosed on 28 May last year. Last patient’s last visit would have been 28 days later, so around 25 June. High level results were famously the subject of an RNS on 20 July; total elapsed time from last patient recruited around seven and a bit weeks.
Sprinter is bigger and multi-national in character but SNG now have major study collaborators in Parexel. Data gathering and cleaning will have been ongoing throughout the study. The analytical templates will be in place. Only the impact of the festive season mitigates in favour of a delay beyond 7-8 weeks from the date of last patient recruited.
All in all, I don’t think that results will be later than mid-January.
The basic science adds up; the analyses and discussions in review papers are favorable; the clinical P2 study demonstrated safety and a strong efficacy signal. What’s not to like?
It’s all about the P3 data now and, perhaps less critically, the outcome of ACTIV-2.