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Herdgehog, competitors like Stallergenes and ALK have already had successful trials that allowed them to register products for venoms, dust mites, trees and grass. AGY has registered 0 products in the past 15 yrs.
So now this statement:
"The Group has also signed a commercial agreement with Biomedical International R+D GmbH for the exclusive rights to ImmunoBON, a patented protein-based oral treatment which was developed to replicate the reduction in incidence of allergy as seen by those who live on a farm with livestock, the so-called "farm effect". In a preclinical study programme, the immunogenicity of the protein formulation with the selected ligands was proven, as well as the capacity to prevent allergic sensitisation1-5. At the scientific congress of the European Academy of Allergy and Clinical Immunology in June 2020, two poster presentations demonstrated that the product significantly reduced allergic symptoms in a mouse model6, and also among patients in a double-blind placebo controlled pilot study7 when compared to placebo treatment."
Should be reassuring? Data based on 2 EAACI P-O-S-T-E-R-S? Wow. I’ll keep that in mind if I ever need to persuade investors I can resort to posters from my childhood bedroom and pass them as scientifically relevant "demonstrations”.
Fool me once, shame on you, fool me twice…?
V.lodge,
Applying your philosophy, you could call passing phase I & II trials as negative, because phase III trials success isn't guaranteed.
And if you think that AGY should be conducting trials, then trying to dismiss as negative news that they will be doing so is contradictory.
Regarding any stricter allergy treatment regulation: that would apply equally to all allergy treatment companies. But it's the larger companies like AGY who would be best equipped to deal with it, and to finance the multi-million pound cost of trials.
I sympathise if you've lost money on AGY in the past, but if you bear a grudge against the company and its management this could be blinding you to the opportunity here.
Hedgehog, I appreciate your exceeding optimism, and would agree with you that this news could be taken either way depending on whether the final results would be positive or not. BUT, and let me put this in simple words for you, I would agree only if this was the case of a company with a proven track record of budget achieved, successful trials and registered products. I am afraid this isn’t the case and that this was a dragging hope to get somewhat relevant results on their end. Many countries are starting to regulate these products and banning them from being sold without clinical studies supporting their claims. Italy has already done that to name one, and Germany is heading that same direction, how many will be next? This is simply unacceptable as the promise to many investors was to have these trials back their claims and giving the products a platform to expand to potential new markets. During the years not only they have failed to do so therefore precluding the possibility to expand, but due to the changing of regulations, they are are risking for the list of countries where these products are ban to grow more and more. How do you call this a success? It really escapes me how people can still have faith in this soon to be shambolic play.
"How is this even remotely positive news ..."
It's not rocket science - a ten year old child could see it.
In simple terms:
If something good is invalidated, that's bad news. And vice versa.
So if a successful trial was invalidated, that would be bad news.
And if a failed trial is invalidated, as in this case, that's good news.
It means that AGY has a second chance with this product which could be an enormous money-spinner for the company, as well as helping a huge number of sufferers.
I look forward to some very exciting newsflow on AGY's multiple trials this year, as per yesterday's RNS:
"We look forward to progressing our portfolio of unique allergy vaccines and helping the millions of patients affected by allergy via our phase III studies with Birch MATA MPL as well as Grass MATA MPL and our upcoming first in human peanut trial."
Two hardly constitutes an alarming amount piling up.
One of which was due to negligence from the CRO (contract research organisation), for which AGY has received millions in compensation.
And one which has just been declared invalid.
And on 24th. June this management reported a profit upgrade, at a time when profit downgrades have become the norm, which is hardly a sign of incompetence:
"Reported revenues for the year ended 30 June 2020 are expected to be at least 4% ahead of last year in constant currency terms. A programme of operating cost efficiencies, together with the timing of the planned research and development expenditure over the 3 years to June 2022, are expected to deliver a net profit for the year significantly above market expectations.
The Board looks forward to providing a further update to shareholders for the year to 30 June 2020 in the week commencing 13 July 2020."
Well, I think you may be confused by the alarming amount of failed trials that AGY is piling up.
That litigation was for the PQ Grass Trial https://www.globenewswire.com/news-release/2019/06/27/1875464/0/en/Allergy-Therapeutics-plc-Successful-litigation-settlement-relating-to-PQ-Grass-Phase-II-Trial.html
The Birch trial is another failure story. Although I can definitely see a constant here. May this be a severe case of bad luck? Or maybe, just maybe, incompetence from the management?
You’re not in possession of the facts. The trial was poorly conducted by a contract research organisation (CRO). If you go back through last years results youll see that they launched legal action and received compensation in the millions. Most if not all biotechs and pharma use CROs. AGY were unlucky but were able to prove incompetence.
They’re clearly very confident in Birch. Good luck to them.
How is this even remotely positive news, as some of you have mentioned, for AGY and most of all for investors? What I see clearly is that they have invested MILLIONS in this study which then resulted invalid! A scientific study is deemed invalid when there is a methodology error. This means, the study was conducted wrongly and millions flew out the window, due to what, an oversight? On a multi-million euro study? How can they try and patch this saying that they still believe in the project? And what if in 2 years (or longer) when phase III is finalized again the results remain inconclusive? Seems to me this is only part of a strategy to avoid admitting that this trial was doomed from the beginning and they have no idea what they’re doing. Honestly I’m tired of them trying to justify the unjustifiable. I just don’t trust them anymore, I had lost confidence for a long time, but this is just getting worse by the second.