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The presentation is after market hours âŠ
1) An interim analysis was performed on SG015 during 2020 based upon approval from the MHRA & results released.
2) Trial was stopped as communicated in May 2021.
3) A final analysis was performed & completed in 2022. This new found was discovered during the final analysis.
Here goes âŠ
WILKINSON T., PA2728, RCT2884, OA3109, PA4278
WILKINSON T., PA1273
MONK P., RCT2884
There is nothing to suggest in the ERS programme that Tom Wilkinson will be representing Synairgen with regard to COPD or the other discussions he is involved in. He may represent Synairgen during the SPRINTER discussion together with P Monk.
Itâs therefore not correct to suggest Synairgen will present about COPD at the ERS unless such evidence is provided.
Manifesto - Can you for heaven sake just leave Ghia alone.
You made a conscious choice to admonish Ghia instead of the original author of the thread and that for sharing in the funny side of conferences.
Itâs undeniable proof that you have an incessant and unhealthy obsession with the guy. You act like a jealous ex girlfriend who cannot get over the fact that you got dumped. You didnât make the cut okay, so move on.
Thx Titania.
Interestingly Synairgen is the only Activ-2 participant not listed in the ACTIV-2 slide.
How funny âŠ
I must point out that following.
âMy takeaway from the AGM is âŠâ the first part of the FULL sentence and should be read together with the second part of the sentence which is â⊠the leash was set at 6months to deliver the progress.â
Separating the two parts provides a meaning contrary to the meaning of the full sentence.
Manifesto - you clearly do not comprehend my post which was not complex in nature.
I have made a general factual statement facing the company which is that it does NOT have the funds to fund further trials. I then went on to list the various scenarios as to how this issue can be resolved one of which was government grants which in turn covers platform trials (as I have mentioned in my post). There is also absolutely NO guarantee weâll be included in another hospital platform trial so you have to consider all options which is what I have done.
So I have absolutely no idea what youâre on about.
Manifesto - you may want to read my full response or read it again as I have covered platform trials. Secondly don't 'shout' at me with exclamation marks. Not appreciated.
Trinityman - in response to your question hereâs my view.
Considerations
1) Synairgen do not have the funds to do further trials whether itâs another phase III Covid-19 or first time round phase III COPD trial.
2) Synairgen have already transitioned from a drug research & development to a commercial company. The âGoâ button has just not been pressed, but the necessary infrastructure (people, partners, manufacturing & processes) has been put in place.
Scenarios
a) Ways in which funds can be obtained: Investors, commercialisation, bank loan, grants & JV.
Investors:
The question is whether investors will have confidence in the company to successfully execute another phase III trial given the recent failure of SPRINTER which shouldâve been a fairly easy one to bag. The answer in my view is âNoâ even if they decide to re-commence COPD alongside covid-19.
Commercialisation:
Should the results, in its individual parts or as a collective, from the SPRINTER deep dive, ACTIV-2 and previously gathered data support Accelerated Approval or EUA, provided the company applies for it and provided itâs successful, only then can commercialisation commence. An upfront payment on any orders should provide the company with sufficient funds to put product on the shelf.
Bank loan to fund manufacturing:
Only possible if Accelerated Approval or EUA is granted and the company have firm orders.
Government grants:
To fund further covid-19 trials and/or manufacturing and commercialisation. Including platform trials under government grants as itâs an indirect grant.
JV:
Failing Government grants or being unsuccessful in applying for Accelerated Approval or EUA then Synairgenâs only option is a JV.
b) With reference to point 2 above Synairgen are technically speaking already a commercial company (albeit without a product), just not in practice which puts it in a difficult situation if commercialisation cannot commence on the back of Accelerated Approval or EUA. In such a scenario Synairgen would need to âre-transitionâ back to a drug development and discovery company with the elephant in the room being the recent hires.
The possible scenarios facing the recent hires are:
- Redundancies
- Another trial would arguably take time so the question is whether these hires would be happy to sit idle until the results of the new trial; or
- Is it possible that they could be contracted to work across both organisations in case of a JV which will at least secure Synairgenâs talent pool.
I recognise this may not be an exhaustive list, although fairly comprehensive, or that others may have a different view. We can only sit out the lull and hope that the data provide us with gems - only then will we know or get a glimpse of the road ahead. Itâs fair to say Synairgen find itself in a corner so they need to come out fighting. Push as hard as possible for Accelerated Approval or EUA.
Trinityman - Iâll respond with my take on things later today; just canât right now. The answer to your question is multifaceted.
The quote dates back to May 2012.
https://www.ipgroupplc.com/media/portfolio-news/2012/2012-05-22
cmww2014 â The answer to your first question is âYesâ. Re your second question the IFN for the Sprinter trial was manufactured by Akron if I remember correctly, if not it wouldâve been manufactured by Rentschler.
Aether - My take on TFGAMâs 26% stake? I guess they have a similar view as mine which is there is value in the product (SNG001) even though Sprinter failed and are extremely disappointed, angry actually, about the failure. If theyâre not, I certainly am as it was avoidable. Complacency combined with poor trial management and control contributed to failure, if not the main reason.
I view their stake of 26% and them increasing it as a positive not because they know more than us, because I donât belief thatâs the case, but because theyâre now in a position to hopefully âinfluenceâ management and we need a shareholder who can walk in with the proverbial baseball bat mentality and kick some a*s. Not saying itâs going to happen, although I do hope so. Unfortunately I donât see RM as ambitious enough to leave no stone unturned to push for commercialisation under the Accelerated Approval programme for example â may I be proven wrong. Will shareholder pressure be required? Maybe.
Iâve just returned from a three week holiday which was a great way to get away from all this. Iâm not going to get excited about anything until we hear something exciting. Talk about possibilities and/or the US government announcing $bn programs mean nothing unless we apply for commercialisation or take part in programs.
With reference to Brand's two options it's the first one. 31 Mar 2022 was the issue date.
https://www.gov.uk/guidance/medicines-register-to-manufacture-import-or-distributor-active-substances
New applications take 60 working days to process, excluding time taken to provide further information or data required. If an inspection is needed it will take 90 days. Variations to registrations that do not need an inspection take 30 working days to process. If the variation needs an inspection it will take 90 working days to process.
(Cont.) was going to add - I couldnât find any text stating you can change endpoints post trial completion.
Manifesto - itâs not a question of it being a mistake or not to release the results. The company had no choice! You should be aware of this.
The suggestion that this change is promising due to findings of the deep dive is grossly misleading without any proof.
You canât change how an endpoint is measured post trial completion. You can while the trial is ongoing under certain circumstances provided you have robust controls in place to prevent any bias.
Howâs this relevant to SNG?
TommyD_19 - there were a number of reasons for my comment. They are
1) I canât see how they couldâve redesigned ACTIV-2 so quickly given we were only told about the pause a week ago
2) The now deleted update referred to âinterim analysisâ which can only refer to the interim analysis carried out during phase II. Interim analysis does not refer to the whole phase II as an interim for phase III.
3) The now deleted update also referred to âcontinuing enrolmentâ. How could we continue enrolment if we havenât even started yet.
Thereâs nothing new about this
I would like the company to pursue every avenue possible, not just platform trials. The FDAâs Accelerated Approvals or Covid-19 equivalent must be pursued. Ruthless ambition, of course within bounds, is whatâs required.