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I agree they wouldn't know during the trial but surely some of the sites would have returned the data having completed their element of the study.
From memory SNG previously stopped a P2 trial as the results were conclusive that SNG was effective and therefore unfair to keep giving individuals placebo
Hence, why they need from November until early 2022 to unblind it.
Alkin - The P3 Sprinter trial is double blinded. The company do NOT have the data yet.
Gareth Walters is hopefully working on those regulatory submissions as we speak. Not long to go now....
Just remember that outside of Activ-2 Synairgen have been running there own P3 trial and they will have a lot of that data already. Prior to the Activ-2 statement they had already started to bolster their team to move things forward and RM was confident before the move to P3.
Happy days...
just interested if they blew the bloody doors off like the last results! surely we can apply for a eua now everyone else seems to have before phase 3?
It was always said within Activ 2 that P2 to P3 would be 'seamless', so assuming it doesn't miss a beat, it may just continue with final results at the end ? Saves time and energy.
Interested to know why investors keen to see P2 data. It was obviously good enough to get us to P3 and will hopefully be good enough to get SNG in hospitals and saving lives (the ultimate goal).
I have to agree with goldforefinger you guys are posting some great stuff. I've come across some very good posters on other boards e.g Myles McNulty and Rowka (back in the day) and have been fortunate to find some really great perspectives.
Fruitsnveg, I have to say Merck, Roche, or GSK would be ideal. Investor meetings e.g. events set up by smaller biotechs attended by big names is always a positive. I have colleagues who worked on both sides of the M&A deals. If SNG is giving a talk or presenting data/ results, it's a key to be aware of who is in attendance. We had this for another company I've invested in quite recently. AZ was the main party interested and I noticed three names and one was exceptionally senior. I know from general conversation that big pharma will be making acquisitions of covid related (or pivoting companies) in the biotech space. They will be making acquisitions of covid companies over the next 6 to 12 months.
Good luck all
Great posts tonight folks.
Thank you for sharing some interesting points.
Credit where it's due Docdaneeka, you did indeed post that interesting study and it underlines the symbiotic relationship between big pharma and companies like Synairgen.
We "will obviously be in a tremendous position when the two P3 trials come in." - I do hope so. I would like to see a more flexible deal brokered if we are successful, where the company is well-funded but maintains control to conduct standalone, which they clearly want to do. Personally, I am less keen on the alternatives for an innovative company like Synairgen.
Marik,
Interesting that you mention past collaborations and the advantage it brings (DD being a key one, it is rigorous and time-consuming at the best of times so any head-start is good). AZ was a definitely a good fit in 2016. But I wouldn't be surprised either if the likes of Merck, or Roche, or GSK show interest too, all examples. I agree with you - it strikes me that the BoD mentality is "to associate with companies that will maximise the benefit of sng001". This has been a key message from Marsden through the months.
The beauty of Synairgen is that they have an extensive Biobank platform technology which adds greatly to their appeal as an attractive bolt-on (back at the time of the AZ deal, it was reported that "The company has a unique method for drug discovery and development having compiled its own advanced human tissue models for respiratory disease directly from patients. It is proving a far more potent method of discovering treatments for conditions such as asthma and chronic obstructive pulmonary disease than experimenting on rats or mice or using lab generated cell lines. Marsden hopes to test more potential new drugs using this platform, pioneered by the University of Southampton, as well as bringing new compounds into the portfolio. “It enables us to flush out the really relevant stuff,” he said of the technology. “And this is the key – it is a much more targeted approach. It is almost like doing a clinical study in man. The AZ deal has validated this approach. We just want to do more of it.". That was then, this is now, and I can't see how their long-term ambitions will have changed. And yes "multiple partnership deals" would be possible, and nice.
One final point, you said "and especially those that attend their investor meetings". Who were you thinking of?
Indeed @Fruitsnveg. Sanofi acquired Principia Biopharma after the Phase 2 data. If we recall back to the days of the AZ in-licence worth up to $225 million and $7.25m upfront. SNG001 for copd at the time didn't have sufficient patients to reach conclusion and AZ got impatient. However, right now with positive p3 data they would pay through the roof. Governments would want to stockpile due to its broad spectrum and any sign of mutations would increase the amount sold. That's part of the reason they had such a large target price (£50 per share) in one of the last notes I read. I would personally hedge on AZ taking them out (not someone like Sanofi see below), and I'm aware of the BoD mentality to associate with companies that will maximise the benefit of sng001. I'm currently on another BB where the company has multiple partnership deals going on, it's evident to me that there are likely to be take out offers in the future from those they've already had dealings (and especially those that attend their investor meetings). This is one of the reasons why collaborations and keeping good relations is so important - a strong proportion of the acquisitions are by previous or current collaboration partners (due to the in process DD).
[addendum: IMO Sanofi doesn't fit the SNG bill of health as their acquisition of Principa was shortly followed by cuts to the company shortly after]
Doc we already have Milo Marsden, or Richard Minderbinder if you prefer? Smooth talking sea dog that he is. TBF though he'll have the company bankers, advisers and lawyers on hand. I have faith in the BOD's ability to drive a good deal(s).
On a separate note, I've been reading that "last year Sanofi acquired Principia Biopharma for USD 3.68bn. The parties had a partnership deal in 2017 to co-develop a multiple sclerosis drug candidate, where Sanofi agreed to provide an upfront payment and future milestones. The buyout transaction came months after that drug candidate reported positive phase 2 data.". It's interesting to see big Pharma doing partnership deals as a potential route to takeover. I have no idea what's in store for us, but there's some interesting avenues out there if P3 delivers.
I would have liked to have seen the data too @Doc83, but I assume it's the way they are conducting the trial. I think it will be significantly better than 50/50, but that's just my opinion.
I’m very positive but I would’ve loved to have seen the Activ-2 data. Hopefully it was amazing, but perhaps it was merely ok and because it’s quite a novel idea they wanted to give it every chance. We just don’t know, so still a lot of uncertainty, even if I do think we are better than 50/50.
5000 doses of sng001 per day at £3000 a pop sold through M&M Enterprises for one year (365 days) makes it 13.65x i.e. £5.475Bn and a sp of about £25 a share. There's no catch there Doc.
My other favourite is This Boy's Life. Resonates on a few levels, particularly reminds me of the Synairgen underdog story. Approval will be one of the greatest accomplishments for a small British biotech.
You are just teasing me and making me blush docdaneeka (:0) I would have taken that as an **even greater** compliment had you not been a fictitious character from one of my all time favourites. But thank you all the same.
@Purple, that is a possibility in some trials. However, I am not sure what the Synairgen teams views will be on this. The positive p2 results from the activ-2 trial corroborate both the COPD and SNG's own phase 2 data on covid. The expectation is for completion (i.e. last patient) around 4 weeks from now. If they are able to release p3 interim data, then it would make a compelling case for emergency use application. To me it would suggest between end of Q421 and Q122.
Are we likely to see interim data from our P3 trial before Q1 2022?