Member Info for Doc.Daneeka

Most of us have no idea how significant the very delayed COPD analysis is. Scinv knows a fair bit more than most on here but his motives are deeply questionable. It IS reasonable to suggest however, that RM wouldn't stand up and make a complete fool of himself in front of the whole industry. His presentation was about the COPD data which his audience had already had a good chance to study.
We're still waiting for an update from that presentation, which has been understandably delayed, but something will be released this week. And we're still waiting for Strive to get going which is still the great white hope for most of us despite all the broohaha about COPD and flu trials.
We're tipoeing out of the "early September " window that Stacey predicted.

I posted previously that there's a good chance they have completed it - and the peer review comment is a strong steer, but as far as we known now it remains paused and incomplete.

Covid is still the play. We have good data from a tiny unfinished COPD P2. The market couldn't care less but that doesn't matter. If we personally are reassured that our money hasn't gone forever - that's all that matters. Strive anouncement anytime now.... The COPD data merely enhances the sellability of the company.

No correction intended Palladin - just an opinion. I'm sure others view Sprinter differently and attribute no blame to Parexel. FDA said the lower dose was not needed but Synairgen/Parexel then decided it mneant the trial could be made smaller and in theory finished more quickly. It was an odd and calamitous decision in retrospect - made on the basis that SG016's data could be easily replicated but without considering the impact SoC would already be having.
A 610 patient P3 is right at the very bottom end of the scale numerically and we've heard strong evidence that just 100 more trialists could have given statistical significance

Morning Palladin I'd disagree strongly with you about Parexel. Appointed in Nov 20 they were supposed to deliver P3 efficiently and at speed. In this interview with Bertrand Sohier (of Parexel) he makes several claims about the company's unique ability to deliver the trial, which it did not deliver on. Synairgen already had fast track status in the UK and US and RM had said this would enable a trial to begin in these locations and the EU. Parexel turned it into a 20 country project which was completely unnecessary, particularly when the trial size was cut to 600 and then failed to deliver on its promise to "seamlessly navigate their respective in-country requirements " He even cited India as an example - a country which didn't ever give full permission for the trial, leavimg the process to local hospitals and only started dosing in June.
We don't know what input Parexel had on the final trial size - but it clearly went along with the idea that losing the lower dose arm was an opportunity to speed the trial up - without considering the impact that a drop from 900 to 600 would seriously impact the trial power.
Nor do we know what input had on the non -collection of samples - which we now know was a huge error - but there's a strong clue in this interview when Sohier is asked about the difficulties of conducting a trial during Covid and says

" Each time we think about a procedure in this type of trial , we have to think about the level of burden on patients, the sites, and the impact on trial timelines ... in this frantic race for an effective treatment we have to balance the "nice to have " procedures with the critically important ones for the scientific and regulatory validity of the trial ...we have to make difficult decisions about what should be done and more importantly what should not be done "

Maybe I'm being unfair to Parexel - maybe these decisions were made bby Philip Monk - but i expressed these views many times in early 2021 - that there was no need for 20 countries to be involved and that a straight UK/US/Europe trial would have been faster - easier to regulate - far easier to collect samples and in the end to recruit more patients. We know RM's fears of losing patients were based on the failures of the Home trial to recruit - when actually what scuppered the home trial was the lack of support for it nationally and Synairgen's failure to promote it.

https://www.outsourcing-pharma.com/Article/2020/11/24/Synairgen-joins-with-Parexel-Biotech-to-study-COVID-19-drug

Pretty sure they booked RM's talk on the back of the COPD data Patagucci. And without an RNS we know it was the main highlight in his presentation

they must have forgotten about the COPD trial don't you think ? Someone cleaning out the staffroom fridge and asking RM what he wanted to do with all the snot.
My old neighbur George would have been a prime candidate for this trial. A WW2 naval veteran he suffered terribly with his chest in later life and I'd often accompany him to St Thomas's A&E where they did what they could for him. He was an apologetic hockler when the infections came and carried a margarine tub with him at all times. If only I'd known about SNG back then I could have had that off him and into the freezer.

amazing post Prion. What a paper !!

3.5 million COPD deaths globally in 2019 - compared to 6.5m total for Covid. It is on the decrease globally as a percentage but overall levels still going up because of population growth. Smoking the overwhelming cause and that has reduced by 30% in the last 30 years. Still a nice pie to get a slice of. but again it requires at least one further large scale trial and possibly 18 -24 months
As I've said before - we're still in the long grass and nothing will move the sp dial until we are on a big well supported trial and even then we won't see anything like our former glory until that trial succeeds - or we're bought out.

Nice theory RM is on at 3.10 US Eatern isn't he ? So we'll know just before bedtime. I guess they could RNS after close of play today ...

MrC Why would you be here yacking on another day of positivity. I'm becoming suspicious that you really do have zero shares. Even the most critical shareholders can see we've had good signalsm recently - and that the new COPD results are beyond signals and really significant.

This is definitely an old interview. He's talking sometime in 2021. After P2 but well before Sprinter.

"statistically significant " is the nugget. And yes Mani - you did say you hoped for something on COPD - well done

Very encouraged by this. We wondered what RM might have and after rummaging down the back of the sofa - here it is.
Raises one key question for me. We've discussed the status of the COPD work before but if Synairgen are still describing the SG015 trial as "paused", with 109 out of the target of 120 - does this not imply it can be resumed ?

and we really do both understand that there are no drugs involved ...

not sure what your objection is Mani - I don't think I've been inconsistent. I'd say most who agree that Ghia's posts have all been very useful on this. You're suspicious of everything we both contribute but anyone reading these posts will see a neutral and objective discussion. There's no real spin good or bad to be attached to Universal. It's good news with a small g - and nobody has really attempted to present it as anything else.

I guess maybe Ghia - but if Synairgen are looking for a pt in a year to 18 months based on this, none of our hopes will have come to fruition.

I don't see it as an insurance policy either. Whatever it discovers it won't say " inhaled interferon therapy is the answer "
And it certainly won't deliver any direct evidence that we haven't already generated ourselves. And we already KNOW our focus for future trials - we could almost write the protocol for a Strive trial on this forum - we don't need this information.

I see it as a side show and here's why. Universal was planned in the Autumn of 2021 - and the partnerships made then, at a time when Synairgen was confidently surging forward, having just passed A2 P2 and being well on the way to final dose in Sprinter.
Maybe it was SSH or Tom Wilkinson's idea or arose out of discussions with Jansen or AZ - but it's easy to see how this academic and theoretical trial might be proposed - almost as an act of collegiality with the wider respiratoraty diseases community, from a confident and enthusiastic company such as ours on the verge of success. Remembering that it's entirely possible that other companies and therapies might benefit more than Synairgen from the work.
That's how I see it - a small side project which coincidentally arrives now and confuses our thinking at a time when we're so desperate for news of ANY trial.
When this arrives it will not provide a sharper focus for SNG, which we hope will be well on the way to authorisation - but it will grow the whole respiratory science knowledge pool.

it's a particularly torturous achronym. "at Admission Longitudinal " is painful

Still don't understand why Universal is so small. I mean not from a Synairgen perspective - as they don't have resources to manage anything more and will hopefully have something much more important to be getting on with - but surely this should be a global study of 10s or thousands of patients of different ethnicities - collecting data for everything and involving many partners.