 Hi cathal, as far as I can tell the 210 days are classed as 'active days' ie week days or even 'days' that the application is worked on which might not be every week day if that makes sense. AGY house broker state an approval decision in 12 to 18 months from submission!
If or lets be positive when the Grass MATA MPL approval is granted in Germany this, from what I can gather, opens it up for automatic EU approval, I would assume after a bit of paper work.
From the Paul-Ehrlich-Institut's (PEI) website:
Mutual Recognition Procedure
The Mutual Recognition Procedure (MRP) allows the pharmaceutical company to obtain a marketing authorisation for a medicinal product that has already been nationally authorised in a Member State of the European Union (EU) / European Economic Area (EEA), known as the Reference Member State (RMS), on the basis of the examination and assessment of the quality, efficacy and safety of that Member State by other participating Member States (Concerned Member States – CMS).
Repeat Use Procedure
Once an MRP (or a DCP) is performed, it may be followed later by other MRPs for obtaining an authorisation in other member states of the European Union (EU) and the European Economic Area (EEA) (Repeat Use Procedure, RUP). If this procedure is to be used, the Reference Member State shall be notified in advance using a special form (see link below under Further Information).
Edit- DCP-- Decentralised Procedure-The procedure for authorising medicines in more than one European Union Member State in parallel. It can be used for medicines that do not need to be authorised via the centralised procedure and have not already been authorised in any Member State.
Guidance Documents
The Paul-Ehrlich-Institut (PEI) has many years of experience in MRPs, in particular as an RMS, and gladly provides its expertise for consultations on the topic.
hxxps://www.pei.de/EN/regulation/marketing-authorisation-human/authorisations/authorisations-node.html |
CathalA good question regarding the next catalyst. I too wondered that and expect an update on FDA discussions may be on the cards. I expect that news flow in the next few months providing that it is positive will bring a good deal of interest here. Especially PROTECT news.I am pleased that in the lull there remains good interest and that they are paying 6.66 for shares.Promising.impo |
MAA via Paul Ehrlich?
Hey All. As an intruduction, I have been a long term holder of AGY so have been through all the pains of thinking I had lost it all to subsequent benefits of having gone large (comparatively) in the 1p placings. Anyway, on to the question. Do we know if the MAA submitted on 25th November is only for Germany? I know the EU application takes 210 days but there is a Germany only option via PEI which I assume is the case here given their history with Germany and highest revenue potential.. I still cant work out though when approval could be granted if it is shorter than the 210 days. Interested to hear anyones thoughts. Could it be longer than 210 days even? I know they followed tbe same path for Pollinex Quattro. That seemed to take 2 years but they were still allowed to sell it. A bit confusing. Wondering when the next catalyst is |
We seem to have two straight line gradients on the three year chart since we reached a bottom with the placing. The second more recent gradient being steeper than the first. I take this as a good thing as the second derivative is positive - which tentatively I may say represents an acceleration trend. |
As holders Jimmyloser we'd all like to see a name change for you to perhaps Jimmywinner ! |
J puff, no argument on that from me. I am now asking myself is a name change for me finally on the cards? Fingers crossed. |
But don't forget that those of us who did have the right to buy a few at 1p also got that privilege from having had a holding prior to that offer - from higher up at up to 30p. So it merely brought the average buy price down a bit for most. Let's not over egg it guys. The future is looking brighter now though in many respects I'd agree there. |
How very dare you! :-)
Forgot about Acarovac (SCIT)which is an injection treatment for HDM (2013) where Oralvac (SLIT) are in drops format.
Better get the dishes done! |
Another top post Banjo. I believe I bought in at 1p per share so isn't that 6 x?Do I have that right?This is rising strongly now as both interest and credibility grows. Faster than expected.impo |
yes, been a great year especially for anyone buying in at start with a 3x profit!
A nice rise too at end of day!
I was having a look at AGY product (Oralvac)for House Dust Might (HDM)this morning which has flat lined regarding sales for last 2 years at about 6% of total sales.
Oralvac is based on the Pollinex Quattro range of vaccines which has been available for about seven years (Edit 14 years).
It's also worth noting that the new Grass MATA MPL (awaiting Germany, leading quickly to Europe approvals while USA FDA approval route starting soon) is also based on the Pollinex Quattro platform but greatly improved, so you would think it could be arranged to treat House Dust Might?
Another one of those 'papers' (Very expensive to purchase) this time relating to House Dust Might, mainly concentrating on the USA market but also the world in general:
House Dust Mite Allergy Market: To Grow at a CAGR of 13.6% from 2024 to 2031
HAL Allergy Group, Allergy Therapeutics
12-24-2024
"According to a new report published by CoherentMI The house dust mite allergy market is estimated to be valued at USD 2.6 Bn in 2024 and is expected to reach USD 5.3 Bn by 2031, growing at a compound annual growth rate (CAGR) of 13.6% from 2024 to 2031."
hxxps://www.openpr.com/news/3796576/house-dust-mite-allergy-market-to-grow-at-a-cagr-of-13-6-from-2024 (just C&P from www.) |
A decent volume of buying today, especially given over a holiday period. |
What a great end to the year and an exceptional turnaround
impo |
Hi Jimmy, it's a good overview of the company and probably fed to 'Proactive' by the house broker after the AGM and share options.
Anyway, Happy Christmas all |
Not sure if 'This is Money' is part of 'Proactive' but the article was repeated yesterday, all good publicity! |
Pollinex Quattro SCIT is AGY original grass/tree pollen therapy with the new GRASS MATA MPL although based on the Pollinex platform is a lot stronger and hence more effective!
The new GRASS MATA MPL therapy is currently going through the German regulatory approval stage along with imminent start to FDA approval in the USA!
Sorry for waffling on, I've had too many mince pies :-)
Edit and I nodded off between the two posts, that's Christmas for you! |
Just out of interest regarding Pollinex Quattro SCIT and the NHS (North West and North Wales):
What is Pollinex Quattro SCIT?
Pollinex Quattro SCIT is a grass and tree pollen therapy used for children with very troublesome hay fever. Four injections are given under the skin. They are usually in the upper arm. Injections have to be given each week for one month on three consecutive years.
The vaccine course is usually given in winter, when the pollen count is at its lowest.
How safe is SCIT?
SCIT is safe. Over 500,000 doses of Pollinex Quattro have been injected worldwide. The medicine is well tolerated in most patients.
hxxps://allergynorthwest.nhs.uk/resources/allergy-leaflets/subcutaneous-immunotherapy-scit/ |
"Consolidation" |
Time will tell as it will be news driven. Over four billion shares in circulation is a lot I'd say so there maybe a consolation at some stage. Small shareholders won't have much of a say in matters given the small float. Most are probably long term holders from this level I'd agree. |
"The total number of shares issued is 4,766,439,938 Ordinary Shares of 0.1 pence each. 92.62% of the shares are not in public hands, as at 13 December 2023."
I brought this up a few weeks/months ago I think with SkyGem Acquisition Limited (ZQ Capital) having 65% and Southern Fox Investments 27.43% leaving only about 7.5% in 'public hands'!
Therefore a good part of the 7.5% will be either held by long term holders (like me although I don't have as many anymore) or been bought over the last year (probably for the longer term) hence the rise in SP!
Again therefore, with the huge potential of AGY over the next year/years where does the share price go during this time as there will come a point where you can't buy any shares or am I being thick? (I've had a few early pints :-) ) |
beccasan, to be fair Italy have never been a major market for AGY at 6% of global sales but that's not to say they can't improve!
Germany is by far the largest market at 49% of global sales.
See Annual Report:
hxxps://www.allergytherapeutics.com/media/1535/00_web_allergy_ar24.pdf |
Exercise of Options and Total Voting Rights
19 December 2024 Allergy Therapeutics (AIM: AGY), the fully integrated commercial biotechnology company specialising in allergy immunotherapies, announces that to rectify an administrative oversight in relation to the exercise of options under the Company's block admission facility, the Company has made an application to the London Stock Exchange for 709,638 ordinary shares of 0.1 pence each to be admitted to trading on AIM. It is expected that these shares will be admitted to trading on AIM on or around 27 December 2024.
The Group's total issued ordinary share capital remains unchanged at 4,766,439,938 ordinary shares, with no shares held in treasury. This figure may be used by shareholders as the denominator for their calculations regarding disclosure obligations. |
Part from an article today:
Allergy Therapeutics: A story of resilience and transformation
Published: 12:32 19 Dec 2024 GMT
Allergy Therapeutics PLC (AIM:AGY, OTC:AGYTF) is writing a story of resilience and transformation. Putting behind it manufacturing setbacks, the company has redefined its trajectory with a bold strategy centred on innovation.
Its pioneering short-course therapies, designed to tackle conditions such as hay fever and peanut allergy, promise not only to disrupt traditional treatments but to drive significant growth and value in the process.
Its August results hinted at a turning point. In the second half of the financial year, the company posted its first revenue growth since 2021, a milestone that signals progress but also serves as a prelude to something potentially transformative.
That journey has already begun with the Grass MATA MPL treatment - for grass pollen allergies - which late last month was submitted for regulatory approval in Germany. If greenlit by the Paul-Ehrlich-Institut (PEI), the treatment could be on the market by this time next year.
“We have worked around the clock to get the trading business back to growth,” says CEO Manuel Llobet.
“The Peanut project is very exciting, but maybe in the short term, more interestingly, is the regulatory submission we have made [for Grass MATA MPL], where the primary endpoint was met.”
Strong balance sheet
More recently, Allergy Therapeutics has strengthened its financial position with a new £40 million debt line from Hayfin Healthcare Opportunities, comprising a £20 million committed five-year term loan and a £20 million uncommitted incremental facility. Additionally, it has increased an existing loan facility by £10 million to £50 million.
This sort of backing suggests Allergy Therapeutics may be onto something big, an assertion supported by analysts at the research house Cavendish.
Using a discounted cash flow model, they have set a price target of 13p for stock in Allergy Therapeutics - a 124% premium to the current share price.
Specifically, the Cavendish number crunchers believe VLP Peanut could achieve blockbuster status in the US with annual sales in excess of $1 billion, while it expects a not-insubstantial $300–400 million peak sales from Grass MATA MPL.
Cavendish is also predicting strong top-line growth to the previously sedentary existing commercial operation and believes the company’s technology provides a strong moat (Warren Buffett’s term for competitive protection) to the business.
Summarising the 37-page research ‘opus’, Cavendish said it believes Allergy Therapeutics has the ability, based on its two key assets, to generate “significant potential future value for shareholders”. |
Hi beccasan, were you that excited with your offering that you felt the need to duplicate your post? :-) |
Lots of communication from Allergy Therapeutics, about lots of unimportant things. Promises, hot air, too bad they forgot to communicate that they are effectively out of the Italian market because essentially the regulatory body does not believe in these products.
hxxps://www.aifa.gov.it/en/-/determina-dts-115/2024-cessazione-del-periodo-di-continuità-terapeutica-medicinali-allergeni- |
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