Member Info for Diversified

Disease Management

https://www.atsjournals.org/doi/pdf/10.1164/ajrccm-conference.2020.201.1_MeetingAbstracts.A5995

Published 14 days ago, reference to ground glass.

“Functional gas exchange metrics derived from HP-129Xe MRI differ in regions of the lung with abnormal CT image texture. Reduced gas exchange in regions of the lung with apparently normal structure may be predictive of disease progression in IPF. This suggests that functional impairments may precede the appearance of structural pathology as disease progresses.”

https://www.radiologybusiness.com/topics/quality/mount-sinai-covid-recovery-center-imaging-radiology

Now our technology would help meet an unmet need and assist with this new setup greatly. This will be one of many new centers around the world no doubt

Can buy more the £2500 at any one time, can sell as much as you want. Market makers happy to take the stock as this is about to pop.

Yesterday’s RNS is the beginning of the story for the COVID19 play, they wouldn’t just release that without knowing there was much more to come!

It says ‘saffari cannot open the page because the address is invalid

Yet it shows me that the group has 8 Members.

Page link is the same, where am I going wrong?

I think that it is fair to say that anything pharmaceutical/biotech/diagnostic will take this opportunity to reallocate certain resources towards COVID19 if appropriate.

We know with POLX they have a conservative evidence based approach to business which was also highlighted in a recent interview by their Nomad.

It would be hard to believe that Polarean were unable to help with imaging in the fight against COVID19, but I think it is important to keep relative perspective and assume a Q3 2021 FDA approval process until told otherwise.

We have lots of evidence to suggest that Polarean is a winner and it is very hard to not get excited. But this is a long term winner long after a COVID vaccine ever comes into play and I am very confident that this will become a multi bagger in time.

With a market cap of only £50m it’s current rise is based purely on the fact that it’s under the radar and undervalued imo.

https://youtu.be/XzhpGZ221x4

Long term investor, great strategy and track record.

Using the ‘find on page’ tool for finding the key words will perhaps help you find out a few key points made about embolism.

Not to add to much wait to a paper coming on for five years old, the tech is continuing to come on leaps and bounds as you would expect.

https://www.diagnosticimaging.com/x-ray/x-ray-ultrasound-can-be-used-manage-pneumonia-children

Imagine if you then bring Xe129 into the equation with 100,000 times clearer imaging.

https://pdfs.semanticscholar.org/0502/4ce634166b297461415fd1b521247de713d7.pdf

I found this of interest when considering Xe129 as a contrast agent for pulmonary embolism imaging. Let’s hope the scientific users that are currently evaluating COVID19 under a non disclosure agreement find some compelling evidence to support the fight against this virus.

I have noted that some PHD students in 129Xe MRI are expecting manuscript submissions to skyrocket in the coming months.

The CTAP FDA process which would give specific permission for POLX to use its technology for emergency use in COVID19 patients only. This would be a good starting point and would help with faster worldwide adoption of our tech. However, I am hoping for a priority review of the tech, this will allow for all applications and then the subsequent hatch waxman approval to follow.

This is still a long shot, but patient management for those who have had COVID19 and return with reduced lung function seems to be a topic of conversation. This is where functional lung imaging and at some point reduced exposure to radiation would be supported by Polarean’s technology. To encourage adoption, I believe it will be the most serious of cases that will be referred onto having a XeMri which is already being referred to as the gold standard.

Referring to many articles about forward growth in the CT/MRI market, we can expect a very exciting future regardless!

https://www.skope.swiss/options-for-mr-imaging-of-recovering-covid-19-patients/

I think it is clear to see that a research paper that is released by our scientific users that helps to validate the ‘gold standard’ of lung function would extremely helpful and would help kick start wider adoption.

Given the fact that our tech has met its primary end point in phase three trials recently, this current unmet need is clearly in demand.

This feels like a coiled spring, any level of sustained volume and it wouldn’t be hard to reach all time highs given the low level of stock available!

Very excited now

To be outlined in the next few weeks via an RNS.

What is your consensus?

Does anyone expect a change to current Q3 guidance with a priority review or fast tracking of the approval process being announced?

Hi Troy boy, are you Craig on twitter?

A very important article, what is your opinion on this? Gas exchange? Red blood cell diffusion?

Our time is coming imo!

Under the current structure, POLX qualify for 10 month period for FDA approval.

A Priority Review is 6 months.

Fast track - The request can be made at any time during the development process and the FDA will review and make a decision within 60 days.

I am no expert when it comes to pulmonary function and my opinion is based on research, this could be right or wrong. As such I am currently happy with the 3Q 2021 guidelines, however COVID19 is an unexpected opportunity to change these guidelines.

From the general meeting we know that POLX are to ask the question re timelines to approval. Due to the FDA fast tracking many components of the industry that are considered beneficial in the fight against COVID19, POLX were to ask the question at the Pre-NDA which was to be held last month. The Pre-NDA gives the FDA 30 days to review and respond, thus why I am expecting an RNS as early as this month with the ‘Pre NDA minutes’ as per other PLC that have held a pre NDA recently.

POLX are exploring application with its scientific users under a non disclosure agreement. From my research and imo only, I believe that the polarizers could be best used in the aftercare of patients who have been discharged from hospital but now have fibrosis of the lung and require an immediate treatment program to help reduce longer term damage. This research would be complimented by significant research our scientific users have already undertaken or are about to complete. With the tech also being able to identify inflammation and gas exchange, it might have an earlier route to market to decide when to use pressurized oxygen or when to inflate the lung as this should only be done if absolutely necessary. Duke University are in amongst the fight in America and have all the resources required to research for application imo.

Regardless of timelines, in accordance with FDA guidance from the very beginning, POLX have taken a very conservative approach to risk throughout the process. Now taking part in a Pre-NDA to further manage risk, unlike a drug biotech approval process, this diagnostic company is doing everything necessary to reduce risk to unbelievable levels. I have no concerns that it will be rejected, especially when you consider 25 odd polarizers are already being used by the top pulmonary researchers in the U.S and elsewhere.

Would be very interested to know yours and others opinions?

I know many believe POLX to be a slow burner, but I believe the gains are to be made from here on in as I believe we have a significant bottleneck of news building as per my previous posts.

We should have a Pre-NDA RNS, containing the minutes of the meeting which should give us an idea of if the general meeting has accepted fast track. I am not fussed either way as hold long term but with anything COVID related seeing multiple returns, the short term potential is massive.

FDA have 30 days to respond to pre NDA meeting and meeting took place around the 18th April, ish!

Something is brewing imo!

On the 18th March Richard said that the pre-NDA meeting was in about a month (3min).

https://youtu.be/pwCaI0anJfg

With the NDA having 30 days to reply to Polarean to outline their expectations and answer any questions.

Following the general meeting on the 1st April and given the fact that they are exploring scientific application for their tech in the fight against Covid, and that they will be asking the question re fast tracking due to the virus. Imo we should be expecting an update with a few weeks as a result of this. Therefore, any rise in price leading up to such a milestone should be expected imo. May could prove to be quite a catalyst for this company.

Yesterday for the first time outside of private investor speculation our NOMAD spoke of the opportunity that is in front of POLX in the same breath of talking about the multiple returns other companies have had when exploring testing and treatments for COVID19.

If ever you wanted to find a company that was a beneficiary, not necessarily as a diagnostic, but client management after the event for long term damage such as fibrosis it would be POLX.

(Covid 19Application)

We know from the funding completion that, they are exploring scientific application with their users. This is in relation to how the lungs are affected after having recovered from the virus.

(Fast tracking)

They do not qualify for any of the FDA's pre-existing fast track designation but they do plan to raise the issue in the upcoming NDA meeting with the FDA under these unique circumstances with the pandemic.

(Priority review)

Under the circumstances they will be requesting a priority review in the pre meeting with the FDA and they will see how it goes.

It therefore comes as no surprise that given the companies prudent approach to business that any announcement that causes an uplift in the share price will no doubt be sustainable as it will be evidence based in a proven tech. It would of been very easy to say publicly that they are exploring application, but when that much is obvious given the tech they have to hand, I like the companies approach.

In order to discuss a priority review given these unique circumstances, a pre NDA meeting that is imminent if not already held, they must be able to justify how they can help with the virus. Therefore, imo, an update can’t be to far away.