Member Info for maestro1

Pdufa is 5th oct, fda is usa time not uk.
Mkts in US open at 2.30pm, will there be enough time to inform us today?

Still think 7.00am tomorrow.

Now there is 13000 mri situated in the US, they get 10% of those and equipment sales is $650m and annual revenue close to $1bn.

Crazy numbers.

"Over the planning horizon of the first 48 months post commercial launch, the Group maintains its intent to address the high end of the US academic and teaching hospital market segment, which comprises approximately the top 1000 institutions nationally having multiple Centres of Excellence in Pulmonary Medicine and Radiology. The combined addressable capital equipment market there for our products approaches US$500M in equipment sales alone, with the consequent drug sales following as laid out in recently published research."

Still think £3 is unrealistic if they get fda approval.

Pjm

Markets open at 2.30pm uk time in the USA, i believe the decision would be made just release us time for the company at pdufa date.

The tech is best and radiation free.

Oapk20

Exactly, the old tech needs to be updated with ours.

https://twitter.com/PolareanImaging/status/1397268027729752067?s=19

Deepjoy

I agree, decision like 7.00am on wed.

Deepjoy if fda approved tomorrow then within 18 months the big boys buy this.

Edit: 1000 peer review journals

Deepjoy

Those forecast figures of 240 machines in 10 years is way off.

25 polarisers are already out for research, over 100peer review journals so the word is out.

Fda Approval is the biggest hurdle.

Three skin

There is already 25 polarisers out there which have been sold for research purpose, once approved i bet my house they will get sales. This tech is needed...

How many sales did avct have when they touched 500m mkt cap?

Nothing to do with ramping, just in the US alone its £150bn industry per annum, add rest of the world. $$$$

This tech is unmet medical need.

Deepjoy

Then you dont understand the technology.

People are forgetting why we invest in the mkt its about future potential of the company. Polx is no different, fda approval and the tech is 100% derisked.

We have had covid stocks like avct rally upto 500m mkt cap for antigen tests. Here at polx we have a tech which is unique and will help many people with chronic lung disease.

If they get fda approval im looking at £3 share price next few weeks.

WBernard

Polx tech is the only tech in the world that can visualise ALL 3 vital aspects of lung functioning.

So mri or ct on its own cannot do this..

Let this sink in, it was the fda who stated do an inferior test with spirometry.

I like to add something further, of course nothing is certain but the xenon 129 tech has over 1000 peer review journals and it would be very difficult for the fda to ignore.

Its been proven the gas is safe and radiation free, it far superior to anything out there, how the fda could turn a blind eye will be mystery. We need to be moving forward and not relying on 40 year old tech which is radioactive.

Medical world need this tech to speed up diagnosis etc etc.

SlF

If HW is not granted then by the time a new company has developed and trialled and approved their tech polx will have taken mkt share especially in US.

Can easily take 5 years for this..

That being said xenon 129 gas is safe to consume and is radiation free.

Heleb

Fingers crossed. :)

Of course fda can refuse.

Polx phase III trials were based on head to head with comparator which is 40 years old and fda approved. Polx met the end point in the trial phase so i am finding it difficult how the fda can refuse.

Imho if it gets refused fda may request further trials to prove it, i cant see it being the end game here if it gets refused. Lung imaging needs to come to the 21 century...

Toepur, lung disease is also bigger market in the world, fum required funding, polx has $40m in bank.

Woodster

I dont think it is priced in mate, if they get fda approval the tech is worth billions.

Bracco purchased blue earth imaging agent for $400m which detects recurrence of prostate cancer, the us mkt is 22bn for this, whereas the chronic lung disease is 150bn mkt in US. You do maths.

Both bracco and blue earth are on our board..