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Thanks Dumbpunter, you could have just said 'I don't think its a takeover because....' and i would have agreed haha - a venrock takeover doesn't add up for me because I haven't seen any evidence of them taking drugs at this stage of development to market. I'm not sure i understand the suggestion that they're buying on behalf of someone else fully either.
Seems very sensible for SNG to do all they can to progress things properly to meet expectations of all stakeholders, be that scientists, academics, investors, financial and corporate worlds, even though some activities (peer review) may only be deemed desirable as opposed to essential. The full package will in time no doubt produce the 'goods' in terms of a product and a commensurate value. I've no doubt (imho) that these will run in parallel and one should not hold back progress of the other irons in the proverbial fire. I have no knowledge but common sense would suggest that those charged with undertaking the review will have some pressure not to stall and hopefully the urgency of getting a product out (that appears to do what it says on the tin, and potentially save lives) will overtake any normal periods to report.
Frank09.. Thank you for that explanation...publication will be good for the scientists and their recognition but as you say Pharma will be looking at the raw data which they will be quite capable of interpreting. I assume they will have access to both Covid and COPD data whereas only Covid has been released for peer review...
I have to agree with Dumbpunter. Although Venrock are not a hedge fund, they work on company growth NOT take overs. However, I would expect them to help Synairgen grow and not just sit quietly - that should include helping in the takeover process - further down the line.
With regards to the review of the hospital data... this is good news (thank you to Graham who contacted them). The publishing process is being expedited for COVID-19 research. I would expect a quick comms style output. The rate limiting process will be the reviewers, (finding & getting a response). Overall this should IMO take around 3-4 weeks, with the publication release within a very short time after. I'm assuming this will be before the end of month - but let's see. The regulatory bodies won't need peer reviewed publications for progressing further (e.g. EUA), but in essence the data won't be public until the publication is released.
My view is that we are still on track and I'm expecting an RNS soon. Exciting times.
GLA
Very correct!
Apart from that - i have seen already a lot of junk in some peer-reviewed journals. That per se does not impress at all regulatory bodies. The study report is what counts and you need professionals with experience to compile and write such study report. Even the very best and fastest need 3-4 weeks. Then regulatory bodies need some time to assess it - yes fast track in this pandemic, but still it takes 2-3 weeks and: neither in FDA, EMA or UK MHRA one scientist alone makes this decision - but a committee is assessing it and makes recommendation and only then the decision will be made by the authorities. Thus, what you need here is patience and trust that the study was well performed.
The 30 years of data would only be to support the safety case. Efficacy against coronavirus is what matters and theres been little evidence to suggest it works in hospitalised patients.
As I understand it, the article in the lancet was withdrawn because of the concerns raised over the heart issues. Again, the withdrawal would still only benefit the safety aspect.
Frank09
Thanks for that response. I have no idea how the process works and I thank you for the info.
So on that I guess its all about the COPD results and hopefully a deal.
GLA
I agree - there is zero requirement at the UK MHRA, European Medicine Agency (EMA, Amsterdam) or FDA that requests to publish the data in a peer-reviewed journal. I have worked for EMA for 4 years (when it was still in Canary Warf, London). In fact the very most big Pharma First seek approval and only some of them publish months later in a peer reviewed journal. Why would a big Pharma publish before getting marketing authorisation? To pre-notify their competitors?
Some scientists would like to see it published on a peer reviewed journal before the give their firm opinion on that Synairgen trial, but drug regulatory bodies do not ask for that - they ask for the full study report with all data, raw data, individual patients data and all details of the trial design, GCP certificate etc. they get much more than what is ever published a peer reviewed journal.
Not encouraging anything. I'm all in and not putting anymore in.
I dont quite understand when someone on this board posts a slant that we should be aware of its classed at a de ramp when its valid info for all to consider?
...and his skin turn Orange..
Oh I wish you hadn't said that Rookie, I'm feeling much worse now.
By the end of November he'll be history, - we live in hope.
NewbieRookie, you trying to encourage some selling with that post? I think Venrock know what their investing in, and that has made me far less concerned by the peer review process. More importantly, RM emphasised from the start that Data was King, there is no way in the world they would have published those extracts without being sure.
B2HS2L
lol.....Come on...something is making his hair go yellow :)
ChrisToffer
30 plus years of Hydro data should have been king but it clearly wasn't when the article was first published in The Lancet.
Hey I hope we are all golden here but I'm just playing devils advocate.
Rookie, - If Trump were taking the larger dose, it might explain some of his tirades and behaviour.
But then again..
Should someone overdosing on Hydroxychloroquine have his finger on the nuclear option?
Check his dosage someone, - he might be sneaking in another dose in his burger.
Re a Peer review even if they knew, which of course they don’t, they are hardly likely to tell investors are they?
They are simply covering their backs in that response. It doesn’t change anything and is only one piece of the jigsaw in any case.
Why would the hydroxychloroquine story make SNG nervous? The proof is in the trial integrity and the data. Data is king. I don't believe for a second that makes SNG nervous. It certainly doesn't make me nervous.
Must be nervous time for Synairgen. Look at Hydroxychloroquine!
Drug has been safe for years, has another peer review on Covid, ends up in the Lancet and gets discredited. Hundreds of doctors complain and ask to see the dataset and the people doing the study had fudged the numbers (literally overdosing people). The Lancet removes the article but the press never report on the fact its safe and saves Covid lives.
What does one do, who do you trust.
Good that you have been seeking some answers Graham, thanks.
"With the challenges caused by COVID, it is unfortunately almost impossible to predict when this is likely to be published."
I'm disappointed for you and us that they could not provide a better response.
The regulatory agencies or licencees will conduct their own review on the full dataset which is not necessarily the case for a peer review. Therefore a peer review, although would strengthen SNGs position, does not stop the company having the regulatory or licencing discussion. There was a very good link shared here a few weeks back on the subject that explained that in detail.
Venrock don’t operate like Private Equity. They would not want to try to acquire control of Synairgen. They see value against the current share price and expect to be able to crystallise a gain probably within a relatively short time frame. They won’t always get their investment thesis right; however as this isn’t an early stage venture I take comfort that they wouldn’t be investing if they weren’t confident in the risk/reward analysis.
Any potential buyer of Synairgen would likely want to acquire 90% of the outstanding shares in order to squeeze out the minority holders. In effect the larger shareholders would have to be happy with the offer price.
If the share price were to spike on takeover rumours the company would need to issue an RNS if it were in takeover discussions. As the share price is trading in a range I don’t see this happening. Equally if the company was in detailed discussions with one or more parties then its likely that they would have been required to issue an RNS to that effect already.
For what it’s worth it looks to me that they may well be sharing information with potential parties who have yet to express a firm enough interest in making offer to trigger the issue of a RNS.
ChrisToffer - the clue is in ‘I work for a hedge fund’ roughly translated meaning ‘I know better than the rest of you’ despite not knowing OUR backgrounds.
Dumb punter- since you explained in some detail how hedge funds invest specifically on a very fixed strategy Ie,long, short etc which they cannot alter you should be able to tell us exactly what Venrock strategy is. FWIW I think they are here for the buy out (takeover)
I’m actually impressed by the speed of progress and the quality of the information put out by Synairgen. Everything has been timely, delays and possible delays have always been well explained.
I think the news has been coming thick and fast.
'With the challenges caused by COVID, it is unfortunately almost impossible to predict when this is likely to be published.'
Hmmmmmm :(
I received a response from Investor relations today after my query yesterday. It is as follows
Good Evening,
I'm currently holding ***k shares. I have been a long time investor in Synairgen. I'm growing increasingly concerned about the negative articles questioning the accuracy of the recent hospital trial data. Can you advise when the next update or webinar or any interaction with shareholders will take place. I know a number of other investors are also concerned that we are going to miss the opportunity to market SNG001. They're are new treatment breakthroughs happening daily and with winter just around the corner we need to make this as widely available as possible.
I urge Synairgen to release some kind of update to investors and generate some more positive publicity before something else overshadows us.
Kind Regards
Response was
Hi Graham,
Thank you for reaching out. In regards to updates on trial data, as you can imagine, Synairgen is currently working as hard as possible to release the rest of the data in a peer reviewed journal, which is clearly a credible route. With the challenges caused by COVID, it is unfortunately almost impossible to predict when this is likely to be published.
Kind regards,