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For me the bit that really stands out from the ACTIV-2 version 7 protocol and recognises SNG001’s potential broad application is the reason given for why non-infused agents have a greater sample size.
I really hope SNG001 progresses to phase III even if it’s only for the amount of data, which will be invaluable, we can obtain from the trial. I’m curious to know what is included in the definition of ‘broader clinical utility’ and what the potential implications are from its broader utility if proven. It might be somewhere in the protocol - just not yet looked for it.
Quote: 'The larger sample size for evaluating non-infused investigational agents reflects the possibility that they would have broader clinical utility than infused agents even if their efficacy was slightly less than that for the (infused) active comparator agent. Specifically, for non-infused investigational agents, the sample size of 800 participants receiving the non-infused investigational agent (and 800 participants concurrently randomized to receive the active comparator agent) was chosen to provide good power to show non-inferiority even if the non-infused investigational agent has a slightly higher underlying true proportion hospitalized/die versus the active comparator agent.'
The wording was taken from the protocol update in mid Aug.
https://clinicaltrials.gov/ct2/history/NCT04518410?A=85&B=86&C=merged#StudyPageTop
I would say the fact that 'phase III' is being mentioned multiples times is not an indication of progression to phase III, instead they've proactively drafted the protocol to provide for such a scenario. I'm taking a more prudent tone for obvious reasons.
Something I did find quite interesting though and it shows the thought that has gone into the trial design as well as the breadth of its scope. For non-infused agents (like SNG001) the phase III sample size is 800 vs 600 for infused agents. The reason given as per the protocol is as follows:
'The larger sample size for evaluating non-infused investigational agents reflects the possibility that they would have broader clinical utility than infused agents even if their efficacy was slightly less than that for the (infused) active comparator agent. Specifically, for non-infused investigational agents, the sample size of 800 participants receiving the non-infused investigational agent (and 800 participants concurrently randomized to receive the active comparator agent) was chosen to provide good power to show non-inferiority even if the non-infused investigational agent has a slightly higher underlying true proportion hospitalized/die versus the active comparator agent.'
SG018 should conclude recruitment in a month’s time. Getting regulatory approval for the trial in Japan will take months! So the answer is no.
As mentioned several times over and over again the ACTIV-2 trial is conducted and managed by the NIAID. As such the company, Synairgen, is not in a position to comment on the trial, unless given permission to, or the prospects of the trial which means they will NOT be commenting on outpatient use for SNG001 until such time that it is appropriate.
If you go back to 30 Apr 2021’s webcast/RNS you will remember the company stating that they are looking to collaborate on future outpatient trials.
And fossil fuels don’t cause global warming and all the effects that come with it? It kills many people too. Maybe we should ask Prof Sir Holgate on the effects of pollution. He did testify in a recent court case.
Instead we should welcome the expertise and knowledge PM can bring to the table when it comes to inhalation and how that can be used to advance inhalation medicine.
Why is it okay for fossil fuel companies to develop green energy, but for a cigarette company it’s not okay to pivot towards health?
Strange indeed … hypocrites being parochial. Time for people to grow up and worry about bigger things in life.
Doc - the below paragraph is from the 30 Apr 2021 RNS. From this my view is that daily assistance from a nurse is not required - you surely don’t need a nurse to call you just to watch you ‘puffing’ on your nebuliser just like there’s no need to have a nurse calling you to watch you taking your pills. It would defeat the whole purpose of outpatient treatment.
‘A further finding from the Home Cohort was that patients can successfully initiate treatment "remotely",self-administering SNG001 at home without the need for a face-to-face meeting with a health care professional, reducing the burden on hospital facilities and minimising the risk of onward infection.’
Doc - once approved SNG001 treatment would not require nurses to provide outpatient care over the 14 day treatment period. Only at the beginning to train patients. From then on they're on their own. For the purposes of a/the trial it is/was required to have nurses calling in daily for each dose to ensure integrity of the trial and to collect data.
Support from governments and/or their health authorities come in different ways and sometimes it's less visible. Most seem to forget the support Synairgen received from the UK's health authorities - if it wasn't for their support SG018 would not have progressed as a far as it has been. Their support for SG016 has also been great, although it could've been better incl for SG018. However, we should be grateful for the value added due to their support.
Conversations about support pertaining to orders are best to be had once Synairgen produce statistically significant results. Any such conversations prior to such results are pure speculation.
For those who are interested in this event.
Future of Healthcare Investment Forum 2021
London Stock Exchange, in partnership with the BioIndustry Association, Consilium Strategic Communications, JP Morgan, MedCity and Numis are pleased to invite you to the 6th annual Future of Healthcare Investment Forum on Tuesday, 12 October 2021 - 14:00 - 16:30 BST.
https://www.lsegissuerservices.com/spark/future-of-healthcare-investment-forum-2021
Agenda
14:00 Welcome & Opening Remarks
14:10 Keynote speaker – Dame Kate Bingham - Managing Partner of SV Health Investors and formerly Chair of the UK Government’s Vaccine Taskforce
14:30 Panel - Innovation and next generation of technologies in Healthcare
15:00 Panel – The direct responders to Covid – the lessons learned
15:30 Keynote speaker - The Rt. Hon. Kwasi Kwarteng MP - Secretary of State for Business, Energy and Industrial Strategy
15:50 Panel - Opportunities in the post-pandemic world
16:20 Closing Remarks
Ndn71 - like the sense of humour there.
Maybe someone could assist with the following. I'm a bit perplexed as to why we only have five sites in the US. It's very few in comparison to other countries given its size. Has this maybe to do with the cost of doing trials at US hospitals and therefore just too expensive to have more sites or would there be another reason?
Fruits - I was making a general comment re the briefings and not aimed at you. In the past there were so much excitement around these WH briefings and never could understand why.
As expected recruitment end date is 30 Nov 2021. (Note that the primary and study completion dates are not interpreted correctly by the person responsible to maintain the protocol. They use these two dates as the ‘recruitment end date’.)
Six new sites added which brings us to 105 in total.
Numbers in square brackets are the new sites.
United States x 5
Argentina x 1 [1]
Belgium x 4
Brazil x 6
Columbia x 3 [1]
France x 6
Germany x 3 [1]
India x 12 [1]
Israel x 6 [1]
Italy x 9 [1]
Mexico x 5
Netherlands x 2
Portugal x 5
Romania x 4
Serbia x 4
Spain x 10
United Kingdom x 20
https://clinicaltrials.gov/ct2/history/NCT04732949?A=6&B=7&C=merged#StudyPageTop
The White House briefings will not contain information relating to Synairgen. It'll only come via official channels which are Synairgen, ACTG and maybe NIH/NIAID.
Fruits - remember when we had the discussion about the manufacturing quantities required for testing the supply chain? Looking into it I remember reading that when you implement a change, like us now wanting to do BFS instead, they need to conduct tests etc and submit documentation to regulators to prove the new technology works. You don’t need to run trials again. So based on that it would not affect ACTIV-2 progression.
It’ll be a morning RNS.
The company was the first to announce progression on 24 Sep 2021. ACTG (who is managing ACTIV-2) published a news release a few days later.
I’ve posted this before, but good to share it again. This lists all the European event driven press releases from Polygon.
Ultimately you want someone like Polygon as a fellow shareholder.
https://www.polygoninv.com/eventdrivenpressreleases/
Fruits - one of Polygon’s strategies is to target companies where they believe there’s a strong likelihood of an event occurring from which they can greatly profit.
To maximise their profits it seems their objective is to own just enough shares to prevent a squeeze out in the event of a take over giving them the ability to ‘force’ a higher price. They’ve already achieved this % holding with the previous RNS so there was no incentive to increase their holding other than purely maximising potential profits.
So in short I’d say they’re in it to profit rather than collecting fees.
I would caution against anyone saying Polygon knows something or that a takeover is on the cards. That’s pure conjecture with no evidence to back it up. I’d say they just see a good opportunity to profit from.