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Doc.Daneeka, as you can appreciate trying to take notes whilst digesting the info can be taxing, at least for me:)
Hopefully Doc83 and Wigster77 will clarify any misunderstandings when they report here tomorrow after their long journey home.
Finally, they stated bio markers and autoantibodies testing for stratification has come on leaps and bounds since Covid.
Which certainly assists Synairgen in their Phase2 trials.
Also the subject of ILI patent life remaining was raised, that was when governmental exclusivity was mentioned by RM.
Post meeting I asked RM about governmental exclusivity (for biologics) as opposed to patent protection, he said if there was only one to choice he would go for governmental exclusivity.
Doc83 & Wigster77 good to catch up again, have a safe journey home.
I’ve done a quick summary, feel free to correct my interpretation or items I may have missed.
1) No comprehensive answer to company overview of timeframes, reading between the lines this will be dictated by the Phase2 element.
2) They are very focused on stratification for these Phase2 trials by both bio makers and autoantibodies.
It was encouraging to hear that they are going to use the assays developed by Casanova (patent applied for around the same time as our Covid application). The tests are produced by another company but not generally available yet, so early stages for them too.
3) From memory the Phase2 elements have will start more or less simultaneously but will probably finish at differing time and will be US and U.K. based (which makes sense).
4) We got the impression that PT’s are not a priority unless the organisers do all the heavy lifting and Synairgen just has to supply SNG001. Whilst appreciative I think the time taken to receive the ACTIV 2 data was a surprise to them. Synairgen’s limited resources will utilised for their own company trials.
5) Future funding I got the impression the Phase2 trials will be crucial for this area going forward.
6) They said they’ve taken on board criticism of communications, bearing in mind they don’t wish to dish out just fluff or words to that effect.
7) Simon Shaw when questioned about TFG he stated they were definitely not insiders.
Impression, still a long way to go therefore I shall remain on the median line neither positive nor negative, which I will say is much better than I was feeling this morning prior to the meeting starting.
Apologies for any typos.
Doc83
Yes I’ll be there, just waiting on my attendance card which by all accounts is being mailed today.
IMO we should first try to nail the BOD on the company overview for ‘timeframes and funding’ for their current plans leading to Phase3 and authorisation and not focus immediately on remuneration, that can come later if their replies are woolly.
I will have my questions ready if I manage to get a look in, see you there.
TP
I believe the small scale company funded targeted trials have come about due to the data coming through from the initial Universal studies which Synairgen have been part of.
So in that respect it should have given them additional insight to hone in on their target cohort for the best chance of success.
Surely the whole question of retaining present staffing levels comes down to timeframes & funding for their announced future plans. If we can get the answer to those questions that will then influence our view on staffing levels.
The saving of a couple of salaries here and there will only achieve us lingering on for a bit longer, we need clarity on their way forward to addressing timeframes and funding.
The only glimmer maybe is TFG appear to not have kicked up regarding staffing levels yet.
Doc83
As far as I’m aware there are no resolutions for Director salary increases which is the correct decision given our financial circumstances, wouldn’t have passed anyway. :)
As far as the NED aggregate increase from 200k to 350k per annum goes it doesn’t appear too onerous given this hasn’t increased for approximately 20years, apparently an oversight saw the limit breached last year. Of course no increase would be preferable however I think this increase is unavoidable given the time since the last increase.
GLA.
Richard Francis is in the field of compliance, much needed when looking towards the end goal of authorisation, they go hand in hand when dealing with NIH etc.
I would assume and hope Richard Hennings is making full use of his contacts in the Pharma world and to that end I would prefer we have someone of that calibre than not.
For Phillip Monk, I would suggest his behind the scenes lead in scientific lab work goes on unabated, everything including possibly the SNG001 formula can be improved upon. Continued scientific work can impact future IP development, the process is never over and neither should it be.
Personally I believe staffing at present levels isn’t the issue if there’s work being carried out which we can only trust there is (I’m sure there there isn’t an old pals act at play). The big issue is for me is “Time Frames and Funding “ for their announced plan’s going forward be it a JV or otherwise for the Phase3 trials and ultimately authorisation.
GLA.
TP
Synairgen certainly need to expedite their plans. Apart from Covid, I suspect the ‘Broad Spectrum angle’ could well involve Phase2 trials.
So in that respect I remain a little concerned with timeframes until one or other indication is authorised.
TP
Regarding the ILI granted patent, come July we’ll have 6years 8months remaining. This can be extended a further 5years under a SPC (Supplementary Protection Certificate) and a further 6months if used for paediatrics.
However, to gain SPC status, SNG001 first has to be authorised in each territory that it is applied for (separately) where patent coverage exists.
This concession is to allow for the time taken for development and authorisation purposes. The extension (SPC) is generally looked upon favourably but in some cases the process can take up to 3years.
Nursing staff ? Not likely to include personal taken on prior to the Sprinter results, unless they will be analysing Universal the results too.
At the AGM RM stated the new hires (pre-Sprinter results ) would still be required for the ongoing heavy workload that would continue into the future. I assumed that to be planning for future trials and the outcomes thereafter.
Ghia,
‘They clearly signposted at the AGM not to expect anything.
But hey January is nearly over and we are exactly where we expected to be based on the boards comments. ‘
My recollections of the AGM are certainly different to the somewhat dour thoughts you recall, there was definitely an upbeat atmosphere for future trial prospects, If you recall Simon Shaw towards the end of the AGM stated that things were really beginning to hot up in the US.
Personally I still have confidence that the BoD weren’t just carrying out a face saving exercise in response to the Sprinter results failure, perhaps at this stage you feel differently.