The latest Investing Matters Podcast episode featuring Jeremy Skillington, CEO of Poolbeg Pharma has just been released. Listen here.
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.
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.
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.
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.
We should get an Eton update around the 12th Feb.
We should have the new UK clinical lab open before the end of Feb and the US lab open in April. Accreditation will take approx another 2 quarters.
From last nights presentation, it sounds like we are ready to announce contracts with pharma companies for parsortix use in pharma drug trials, testing for PD-L1. (we are only liquid bio company that can do this). We don't have to wait for accreditation to do this. This contract news could come anytime in the next 6 weeks.
The $8bn purchase of Grail by Illumina will have really shaken up the liquid biopsy space. The whole sector is now in the spotlight and getting the recognition it deserves.
I was previously definitely of the mind that only post-FDA would Angle come into play. I would now be surprised if there were not high-level discussions in many board rooms along the lines of we can't afford to be left behind who can we buy ?
" Galleri (Grail) is expected to launch commercially in 2021 as a multi-cancer, laboratory developed test for early cancer detection from blood. "
Ironically Allumina could really do with buying AGL. If they used Grail to detect cancer they could use parsortix to monitor it and test drugs on captured cancer cells. At the moment Grail is not offering a compelling test as very few places would be able to do anything for you if Galleri says we found cancer. A scan may not even be able to find the cancer.
Illumina, Abbott, Qiagen, Philips etc etc must all now be looking at us. Who is going to be the first to blink ?
GRAIL’s test can detect more than 50 cancers across all stages, with a very low false positive rate of less than one percent. When a cancer signal is detected, our test can identify where in the body the cancer is located with high accuracy.
Grail has filed to go public. The company DOES NOT have a product or revenue yet -------$6bn
Grail’s biggest investor is DNA machine maker Illumina, and Amazon’s Jeff Bezos is also an investor.
$6bn ............This is unbelievable news........................................
Just goes to show list in America, get a great name, sell a dream and get a $6bn valuation.............
For the share price to be static for so long it and not move post the good news last night it would appear that a large sell order being worked.
When it's complete I would expect the share price to quickly move up into the 60's.
A Nasdaq listing post FDA approval could well see a £1bn market cap as the potential for the parsortix platform becomes undeniable. Once you realise what the parsortix platform can do and what that means over the next 5-10 yrs for cancer diagnostics then it is very hard to put a fig on its value.
The ultimate goal for the platform is being used as a screening for all cancers just like the PSA test is now.
It is hard to imagine that a big player won't want to be in control of parsortix .