Member Info for andypa

I'm also invested in AGL and the CEO noted one of the biggest risks of getting FDA approval was someone new coming on board in the FDA and suddenly having a whole new set of criteria.

Hopefully get a research note out this week which will shed more light on the further work required.

I think at this stage POLX may want further clarity from the FDA of exactly what extra work they are asking for.

"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.

From the webinar last night Martin appeared very confident of approval of chronocort at the end of this month.

All questions answered on time and not many questions..........I imagine the nature and quantity of questions would give an indication as to whether the regulator was happy with the submission.

I'm 90% confident of a positive result for Chronocort, but you never know , so fingers crossed.

Chester here you go from the interims

"Diurnal anticipates receiving recommendation for approval of Chronocort® in Europe in March 2021, with formal approval from the European Commission to follow in Q2 2021. In parallel with the MAA submission, Diurnal will apply for confirmation of Orphan Drug Status for Chronocort® in CAH."

In order for a laboratory to become accredited it must not only prove it has a quality system that meets the specific requirements, it must also prove it is technically competent, i.e. meets the claimed measurement accuracies and traceability, for the testing or calibrations listed on its Scope of Accreditation.

I'm guessing that we are waiting for accreditation for the UK lab and once given then the PD-L1 service contracts can be signed and RNSed :o) AN did mention contractS, so maybe one in the UK and also one for the US lab when it is accredited in April / May.

https://www.youtube.com/watch?v=5gx3zy9iJes from 19min 50secs

It going to take another couple of years plus, but getting approval for use of Chronocort for AI will open c $2bn market. Approval next month really will be a big milestone and open up this new huge market opportunity in AI.

DNL has a very healthy pipeline before you take account of the potential of DITEST. Once the market realises the chronocort AI opportunity then we should be in for a big re rate.

In 3-5 years DNL's share price maybe in double digit pounds if we can get approval for AI use.

I imagine the $2.5m from Eton will be arriving from Eton in the next couple of mths :o) Just waiting for Orphan drug approval and then Eton will pay us

For me the reason why I'm holding out for a much higher share price is Grail 's $8bn valuation and Thrive $2.4bn valuation.

This has thrown out all normal measures that I would use to value a company. AN can use these as bench mark valuations to reject any cheeky low ball bids.

There is definitely a large US order being filled. Has been going on for a number of weeks. If you must sell do so in the afternoon to get best price.

NASDAQ listing will be approx 6mths after FDA approval. I don't think we will ever make it that far. There are approx 5 or 6 companies that will NEED to buy us. Illumina (Grail) or Exact sciences (Thrive) because our tech is better / complementary and they don't want to look stupid having already paid many billions for companies with no FDA approval, only looking at DNA from dead cells, no cluster info, PD-L1 expression or ability to culture live CTC cells.

Can Abbott, Qiagen or Philips etc allow another company to buy this and leave them behind for many many years. This tech will change the face of cancer diagnosis for the next 15-20yrs. It is going to be worth 10's of billions to the company that can fully exploit it.

What is becoming increasingly transparent over the last year that just counting the number of CTC's in a blood sample is a very crude measure and that clusters etc are far more important. With the unique, simple and gentle way that parsortix captures cells (including clusters) future discoveries of important cellular information will be made using parsortix or parsortix will be capable of providing the information. Each new discovery further differentiates parsortix from all other CTC capture devices.

AN has repeatedly stated June as the earliest..................

The question I have is do Eton owe us $2.5m as the first sale of Alkindi must have occurred already ???

Eton clearly have high hopes for Alkindi. Early indications must be positive otherwise they would not have bought the Canadian rights. Alkindi was only launched in Nov so I would still expect numbers to be tiny, but should be accumulating rapidly. It would be interesting to hear the number of patients now taking Alkindi at the end of Dec, maybe 50-100 ????

Reuter's miss reported that Q4 2020 results would be today. Hopefully, get confirmation from Eton of when they will be releasing results this week. Results have historically been released on the 12th of the month.

Lignum spot on - most of the Alkindi deals will be more or less copy and paste for Chronocort. Once the reps are trained and selling Alkindi, it will require very little effort to add Chronocort to a reps bag.

I think it is the value gap between us and our peers that gets everyone very excited.

It does seem that there is a theme of the share price rising in the afternoons. It does appear to indicate that our America friends are buying. Every time I consider selling some I remind myself that Grail sold for $8bn and Thrive for $2.4bn.

I think that Grail and Thrive would both be keen to add parsortix capabilities to their offerings. It would make it a far more compelling product. Bizzarely our perceived biggest competition could end up being our biggest customers.