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Obviously, Abbot knows all about AGL with the PathVysion HER-2 DNA FISH Probe kits being used for for ANGLE's ANG-002 FDA study.
Dibs61 - I did let out a purr when I read the link you provided. Let the bidding war begin. AGL gone before x mas.
No sales revenue is irrelevant as whoever controls AGL will control the future backbone all liquid biopsy testing for the next 10 yrs. We deliver the intact CTC's and everyone else can then build diagnostic tests on top......................
The key is whether they are now seeing a sustained ramp-up in testing and are willing to start issuing guidance.
Jan - Mar quarter is going to be around $1m. Management will obviously have a good idea of the expected rev in this quarter as we are nearly 2/3 through it. All will be revealed in about 3 weeks.
Not issuing guidance to avoid tanking the share price ship has sailed ........ and we have raised money, so I think they will start guiding this quarter hopefully.
Revenue for Jan to Mar quarter will be around $1.1m I would guess.
The key question is are they willing to provide guidance for April - June quarter ??? First VA sales have been made.
It is worth noting that something like 75% of renals addressable market is people aged over 65 so getting medicare coverage will be a big milestone.
The way the share price is falling we are being priced for failure. Likely to be some 25%+ up days over the next 6 months as positive news hits. The big question is how low do we fall to first ???
In a market like this words no longer count, until we show sales this is a jam tomorrow stock which when everything is crashing is not where anyone wants to be.
Everything I have read and researched points to this being a big winner, but sales traction is taking longer than hoped, maybe 6 mths behind analysts' forecasts.
Getting medicare, FDA and a big pharma deal over the next 12mths and an end to the bear market should transform the share price as sales start to accelerate.
SLF - you are correct POLX machine works with all brands and is independent of the MRI machine.
The point I am making very poorly is that say GE bought POLX then they may strategically decide that the POLX machine is only available to those who already own or buy a GE MRI giving them a competitive advantage. GE already have a worldwide sales force and maintenance contracts etc so would be a nice add on. Buying POLX would be pocket change for GE.
Accountant - I agree one of the big 3 MRI suppliers controlling polx would not be good for patients and limit access. I just think that strategically if I was one of the big 3 and polx receives FDA clearance I would want to own it!
Alternatively, as pjm noted Bracco are going to want to have their say as well !!
There is a fair chance one of the big MRI machine suppliers General Electric, Siemens, and Philips will buy Polarean.
WHY ??
Because whichever of the big 3 acquires us will be able to differentiate itself from the competition. Nice to able to say that they can offer enhanced pulmonary imaging etc !! I'm no expert, but I imagine that selling MRI machines is now a fairly stable low growth business., but then some new tech arrives ......
Any revenue forecasts for next year ? Q1 this year looks around $3-$4m based on MS. The big question is next years revenue - $50m ?? $50m would mean the current mkt cap was approx 8* next years revenue !!! That's still not cheap ??
Any thoughts ??
I think it was a case that POLX had a fixed approval date with the FDA unlike most other companies Renal / AGL etc and therefore they had to approve or CRL, they couldn't just ask more questions to delay. The easy option for the FDA was to kick the decision into the long grass and issue a CRL, as they had managed to do the work to approve it. Also being a small company we didn't have a team of lobbyists to help influence the decision and make us a priority.
"These issues are mostly technical or manufacturing-related in nature and centre around the Xenon hyperpolariser system."
This sounds like it may have something to do with the repeatability / sterility / consistency of hyperpolarised Xenon in every bag produced ??? About proving quality control...................which is understandable, but also slightly perverse when you consider what the alternatives are.
I imagine that POLX management said to the FDA 1-2 mths ago "have you got everything you need........are you happy with all the information " etc etc.................... so there was clearly a **** up regarding what was required or communicating with the FDA. No doubt the company hired expert consultants to help as well......someone drop the ball. Clearly POLX now urgently want to seek further clarity by meeting with the FDA.
In the short term an updated broker note should shed more light on what extra work is needed.
I'm now a lot more nervous today than yesterday, this delay is surprising..................
Putting my positive hat on...............they only got positive news late last night US time and decided for max impact to announce the news at the US open together with intention of NASDAQ listing etc.......................fingers crossed
Highly likely a leak as we were one of the first items on the agenda, so a decision has probably already been made.