Polarean Imaging Share Discussion Threads

[pre] 06/10/2021 15:17

No wonder there has been a persisted seller, did they know something or sense refusal?

[neo26] 06/10/2021 15:15

Fda are fda

[mw8156] 06/10/2021 15:14

Disaster also for AmativCT and Dr Paul Jourdan who, having attended their presentation at the LSE 2 yr ago, was convinced, like I was by the quality of their images so there must be some fundamental problem with the polariser or more information required not admitted at that time. They were working with eminent institutions in the US such as Cincinnati Children's, etc.

[stallone10] 06/10/2021 15:13

So I see 20p coming

[mjb252] 06/10/2021 15:07

Spot on. Why else would they slow time a firm that they have been in open dialogue with for so long. Riddled

[mw8156] 06/10/2021 15:06

sold out-a disaster, is the problem with reliably polarising the gas?

[chesty1] 06/10/2021 15:03

Nearly two years worth of profits wiped out in 30 mins.....

That dip this am was folks in the know surely!

[gregb] 06/10/2021 15:00

Me.Probably double up at some point. I'll see what the Company says first.

[slicethepie] 06/10/2021 14:59

The fda are political, witness they stopped the leading Pharma company in covid vaccination technology (inovio) claiming they needed further information on its delivery method despite the fact that this technology had been used for many years. This allowed big Pharma to win the race.

[chesty1] 06/10/2021 14:57

Ouch sorry longs! fingers crossed they can sort it out.

[timbo003] 06/10/2021 14:52

Glass half full and all that....

There may be an outside chance that this could present a long term opportunity, i.e. if they modify the polarisation apparatus to comply with FDA's requests and then secure new (20 year) IP concerning the improvments

[markstevenkirby80] 06/10/2021 14:51

Me I have to now

[alloa2003] 06/10/2021 14:49

If they can resolve the issues quickly, current levels would be the buy of the century. However, as a holder, if they cant resolve the issues the company is effectively worth near zero. You buys your shares, you takes you chance.

However you wrap it up, it is a bit of a shocker!

[hunter157] 06/10/2021 14:49

What a day :-( anyone gonna sit and wait?

[ny boy] 06/10/2021 14:48

Will add once the dust settles!

[timbo003] 06/10/2021 14:46

From the RNS:

These issues are mostly technical or manufacturing-related in nature and centre around the Xenon hyperpolariser system.


The issues do not appear to be anything to do with the clinical data (which is a relief) and so the timeline for sorting out these issues is likely to be measured in months rather than years.

[trickydicky1] 06/10/2021 14:42

This is curious.

I struggle to see how Allis and Hullihen so mis-read the FDA.

Unless the FDA is re-thinking its modus operandii post Covid? They are not the only ones to have received unexpected decisions in recent months.

Bystander, but feeling very lucky rather than clever.

[slicethepie] 06/10/2021 14:41

As an aside this is technology that improves outcomes massively, witness the fact that so may machines are in use, this is also a help in covid. If this was a drug it would be understandable. Politics at play?

[alloa2003] 06/10/2021 14:39

Aye Playful, its not a pretty sight.

[jaforsadi] 06/10/2021 14:38

Only scalpers now buying hoping for a bounce They will soon sell out before it goes sub 40

[playful] 06/10/2021 14:37

What carnage

[liam1om] 06/10/2021 14:32

Dissapointing news, but a great buying opportunity:

The FDA has determined it is unable to approve the NDA in its present form and has provided a list of issues to be addressed by the Company. These issues are mostly technical or manufacturing-related in nature and centre around the Xenon hyperpolariser system. Polarean will work to address the issues identified by the FDA with a view to resubmitting the NDA and securing FDA approval as quickly as possible. Following resubmission of the NDA, it is expected that the FDA review period will take 2-6 months.

They will be back, just a matter of holding now until they resubmit.

[neo26] 06/10/2021 14:25

Now we know about the persistent seller.