Allergy Therapeutics Share Discussion Threads

[jimmyloser] 31/3/2015 17:40

Agreed. Y trades

[audigger] 31/3/2015 17:18

Loan notes converted today, placing shares on AIM tomorrow. Price action thereafter will be interesting!

[aruntim] 31/3/2015 16:15

What's happened?

[jimmyloser] 31/3/2015 15:54

WE ARE DESPERATE FOR YOUR SHARES !!!!

[jimmyloser] 27/3/2015 17:30

Interesting Y trades again today.

The FDA has agreed in principle the synopses and is now reviewing the full protocol and statistical analysis to allow the clinical development to start; this permission is expected to be granted during March 2015..

RNS - Monday? Followed by result of extraordinary meeting?

[jimmyloser] 24/3/2015 22:55

Double header of news expected within days.

Look before you leap.

[jimmyloser] 24/3/2015 18:48

A number of T+ trades going through?

[jimmyloser] 17/3/2015 07:59

The FDA has agreed in principle the synopses and is now reviewing the full protocol and statistical analysis to allow the clinical development to start; this permission is expected to be granted during....... March 2015.

[audigger] 10/3/2015 07:25

So we finally have clarity of the business strategy and I have to say I'm pleased they are going alone. The opportunity here is huge. Whilst we'll take a small-term hit due the placing, increased visibility of AGY now it has a clear strategy will drive the share price forward on a wave of expectation which I expect to happen once FDA sign-off on the trial protocol. I will definitely now be adding and at a discount to today's price!

[jimmyloser] 10/3/2015 07:12

One million percent expected and not at all surprised

Another massive pat on the back to the board of Allergy - Love it!

In for the long term.

[audigger] 02/3/2015 07:59

From a regulatory point of view its clear they have a plan of action and its encouraging they are still in dialogue with FDA as this is key to ensuring that the trial design meets regulatory expectations. However, the commercial strategy still remains unclear. I don't have a major issue with this as any potential partner would want the regulatory risk to be minimal. However, last year AGY set an expectation that the commercial stratey would be known end of 4Q 2014 or early 2015. This hasn't happened. Given the EU business continues to increase market share and is profitable and that the regulatory hurdles in Germany are likely to be sorted this year, there is enough to support the current share price and a call cash remains unlikely unless its needed to fund the US strategy. So my glass is two thirds full on AGY at present......patience required!

[jimmyloser] 02/3/2015 07:44

Have you read the same statement as I have this morning?

You don't just start to stick hypodermics into American citizens by clicking your fingers.

Brilliant news and progress very clear in my eyes.

Mid 2016 should be the timeline. A lot of water to go under the bridge before then I suspect - just cross our fingers that they are not snapped up.

imho/dyor etc

[jimmyloser] 02/3/2015 07:40

Launching a new drug into the USA just doesn't happen by clicking your fingers.
See what the market makes of it. Very encouraging statement for serious investors this morning.

Well done and thanks to all at AGY.

[audigger] 02/3/2015 07:38

Solid results but no news of any significant developments in the US as yet so their strategy to get to market in the US remains unclear. share price reaction dificult to gauge as ever with AIM shares....

[jess1] 02/3/2015 07:36

US disappointing still long wait ahead

[jimmyloser] 02/3/2015 07:07

A very good morning to one and all and a huge thank you from me to the folks at AGY and also Cube Boss.


Outlook

The Company remains excited about the prospects for its future. Having strengthened the R&D and Regulatory teams, the Company has focussed on dialogue with the US FDA and the prospects of further clinical activities in the US. In the next six months, the Company is expecting to resume clinical trials to progress the major opportunity in the US into the next stage of the Company's continued growth.

Whilst markets in Europe are expected to remain flat in the near future, the Company will continue to drive further market penetration with a portfolio of short and ultrashort course aluminium free allergy vaccines, which are increasingly becoming the treatment of choice with prescribers. This should also allow us to improve margins through leveraging the improved manufacturing facilities we have put in place.

Peter Jensen

Chairman

Manuel Llobet

Chief Executive Officer

27 February 2015

[jimmyloser] 01/3/2015 07:05

THIS TIME LAST YEAR

MARCH 2014 Manuel Llobet CEO

On the other side of the Atlantic, the positive recommendation by the Food and Drug Administration's (FDA) advisory committee for several sublingual allergy vaccines suggests that the US market will shortly be opening up for well-characterized, pharmaceutical quality allergy vaccines. These pending changes to that market's dynamics, along with our own progress made with the North American regulatory authorities, underscores our confidence that the US market will emerge as a valuable market for registered allergy vaccines. We continue to explore our strategic options for the development and commercialisation of Pollinex Quattro in these territories

"where we see a compelling opportunity to be first to market in the subcutaneous segment with short-course products that could revolutionise the way such immunotherapy treatments are administered".

The meeting builds on the successful discussions held with the FDA, which resulted in the lifting of the clinical hold on the Company's clinical studies using vaccines containing the adjuvant monophosphoryl lipid A (MPL) in August 2012. Health Canada similarly had a hold on CTAs involving MPL. These decisions enable the Company to plan the start of the G304 study, which will involve two clinical sites in the US as well as one in Canada.
The study, involving over 600 patients, will use multiple Environmental Exposure Chambers (EECs), allowing for controlled allergen exposure, to study the response to treatment with the new Pollinex Quattro Grass MATA MPL (0.5ml) compared to Grass MATA (0.5ml) and placebo.
The G304 study will also further define the safety and efficacy advantages of the addition of MPL to the MATA products which were previously seen in Allergy Therapeutics' Pollinex Quattro Ragweed MATA MPL (0.5 ml). The full results of this trial, where a relative mean improvement of Pollinex Quattro Ragweed vs placebo of 48% (p < 0.05) and a median improvement relative to placebo of 82% was reported, were recently published in the January print edition of The Journal of Allergy and Clinical Immunology (JACI) and summarised in the Company press release dated 27 January 2014.

[audigger] 28/2/2015 18:02

This sets a clear expectation of significant news which, if not forthcoming, will mean a significant drop in the share price And of course the opposite will be true if we get some significant good news!

[jimmyloser] 28/2/2015 17:07

22 September 2014

The positive recommendations of the Food and Drug Administration (FDA) for several sublingual vaccines have resulted in three products being rolled out to the market. This change to the market reinforces our confidence in the North American opportunity. Our discussions over the year with the FDA and the Canadian Health authorities have been positive. We are planning a G304 phase III study involving two clinical sites, one in the USA and one in Canada, involving 600 patients, who will use multiple environmental exposure chambers allowing for a controlled allergen exposure to study the response to the MATA MPL, Grass MATA and a placebo.

Outlook
Finally, we are very excited by the opportunity in the US market, and in making the transformational opportunity happen by developing an agreed roadmap to registering MATA MPL Grass in the US and we continue to explore a range of options to exploit this commercial opportunity.

[jimmyloser] 27/2/2015 16:00

TIME TO DELIVER????


With a suitable partner, Pollinex(R) Quattro could be the first registered subcutaneous vaccine to be launched in the US market, which is predominantly a subcutaneous market. The product could revolutionise treatment for grass related allergic rhinitis in the US by providing effective, fast-acting treatment to allergy sufferers. Pollinex(R) Quattro involves four pre-seasonal allergy vaccine injections administered over a month, making it an attractive alternative to the prolonged course of weekly to monthly injections over three years that is currently available with the allergen extract vaccines used in the United States.

Peter Jensen

Chairman

Manuel Llobet

Chief Executive Officer

25 March 2013

[jimmyloser] 24/2/2015 21:44

I agree and believe nothing matters as much as Monday doesMust admit that a placement or a fund raising would not surprise me.Impo, we have another twelve months to wait here but no strategic news on Monday would disappoint me.

[richsawko] 24/2/2015 21:21

Pull back has been on tiny volume so no worries as far as I am concerned. Still see this rising up to and beyond results