The latest Investing Matters Podcast episode featuring Jeremy Skillington, CEO of Poolbeg Pharma has just been released. Listen here.
People are forgetting there is more news to come, next due is the approval of the same drug in the UK (due to Brexit), being a long term DNL holder, I have also noticed that DNL tend to release RNS messages in succession (example see 11,12,13,14 January, 28,29,30 October), some of this could be re-posting news / research notes.
The line extension for Efmody (Chronocort) for treatment of AI is a way off, but this is a substantial opportunity for increased turnover.
ALB
When are we due regulatory approval in the UK?!
Hold on to your shares.
Scored, well done on your conviction with this share and your continued buying right up to this week - fair play!
Couldn't comment earlier, stuck out on my only job this week, rain, hail and very little mobile coverage - what a day for news!
I think there will be some press coverage over the next week or so, hopefully in the likes of IC, I think the Times or Telegraph and the Mail have all covered this in the past, so possibly a "haven't we done well" from the Daily Mail.
What is really great is that this is an Aim stock, with two approved products and a strong pipeline, the Management Team have proved they can deliver and this takes a lot of the risk off the table.
DNL are presenting to ShareSoc next month, so it will be interesting to see what they have to say. I believe the price will stabilise and start to move towards and above 100p in the next month or so.
Oh. And 608 trades today!! Things have certainly changed.
Seriously happy for you! (and all the others with faith or good timing).
https://www.calvinepartners.com/diurnal-group-efmody-approval
www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-22-25-march-2021
Approved already
Oh, I forgot the link to the LTIP, see for yourself;
https://otp.tools.investis.com/clients/uk/diurnal_limited/rns/regulatory-story.aspx?cid=1282&newsid=1439666
Just a friendly reminder for long term holders and a heads up to new investors. The DNL Management Team are well motivated by a LTIP which will reward them with £1m + in shares providing the business growth and development criteria are met. This includes;
· Achieving a target share price of 100 pence for a three-month rolling period during the five years following grant
· Confirmation from the US FDA of progression of DITEST™ to Phase 3 development
· Global Alkindi® and Chronocort® sales for the year ended 30 June 2023 in line with Company forecasts
· Submission of Marketing Authorisation Application in Japan for Alkindi® or a Japanese partner in place
· Chronocort® approved in adrenal insufficiency (AI) in at least one major global territory
When everything on this list is achieved, a £1 share price will be a distant memory.
IMO, this share will go a long way.
Thanks Scored, yes, that's the number of shares the mm's HAVE to buy or sell at the bid/offer price, it could do with being higher but if you are struggling to buy or sell - 1500 is the number.
This should mean you get a trade (at the bid/offer) but not necessarily the best price buying more often gets you within the bid offer spread.
The only time you shouldn't be able to get a quote on 1500 is during auction.
Great price moves today. GLA.
Does anyone know the current NMS for DNL?
This is a much better version of the same timeline - takes you through step by step.
https://www.almacgroup.com/wp-content/uploads/2019/09/Introduction-to-the-EU-regulatory-submission-timeline-David-McCoubrey.pdf
Interesting document, apparently CHMP opinion within 200 days is a legal requirement, not sure if that means working days. So it shouldn't be delayed.
Day 1 = passing validation (which was 1st April 2020), of course there is a "stopped clock" period for up to 3 months for answering questions.
https://www.ema.europa.eu/en/documents/presentation/marketing-authorisation-evaluation-process-dr-evdokia-korakianiti_en.pdf
DNL is on page 9 of 38 of the CHMP agenda, not sure how quickly they cover each point, but we could hear news before the end of the week.
https://www.ema.europa.eu/en/documents/agenda/agenda-chmp-agenda-22-25-march-2021-meeting_en.pdf
take a look at Futura Medical (FUM), they have received some kind of drug approval today and are up 50% plus this morning.
Not a share I follow but perhaps a sign of potential moves here.
ATB
Hi Scored, I believe Eton may help with the US approval, I think I read this somewhere, they have a good relationship with the regulator. In their latest presentation they have 2025 as the US approval data (I'm surprised it's that far out). We should get European approval for using Chronocort for AI well before that.
On the funds (mainly trusts), yes, there is a fee, but for that fee I get access to some great investors (and their access to the businesses they invest in), their research teams, their gearing (trusts can deploy borrowing when there are opportunities), and taking Edinburgh (EDIN) as an example, I have gained 6% since purchase earlier this year, but it is still trading on a 6.5% discount to its holdings. The annual management charge is 0.55%, so as it was on a 10% plus discount when I purchased - it seemed great value. My strategy with EDIN is chasing the recovery theme in the UK post BREXIT and post COVID.
You are right, I could buy the portfolio, but there are 44 holdings (and I can only see the full PAST portfolio from the annual report). But, if I buy the portfolio, I will pay £220 minimum in charges (not including stamp duty). I would have to spend a minimum of £40k to get better value than the trust, plus I would pay full price (I got the portfolio 10% off through the trust).
Like many, I use trusts as a part my portfolio (currently 20%) - they should do well, I get dividends every month (EDIN pays 4%). They are sensible and well managed. I also get exposure to markets I don't understand (Asia, USA, Emerging Markets and themes like mining), although I sold Scottish Mortgage late last year for a good profit which saved my 2020.
I have some big FTSE names, LSE, TSCO, DGE, LLOY, etc (around 25% counting FTSE350 names)
Then I have small companies for growth (around 50%) - well diversified but like you I'm overweight DNL, I am hoping to re-deploy some gains (this year or next) and get back within my portfolio rules on DNL - my max should be 10% of portfolio, only DNL is above this.
ALB
Totally agree, there will be big winners and big losers plus takeovers I guess.
For the losers, I have been looking at MANO (insolvency litigation), their SP is well down and seems to be recovering on a recent update. Still researching.
I have recently purchased Marshalls (construction materials), Edinburgh Trust, HL., LSE, Temple Bar Trust, Temple Bar Emerging Trust, TSCO as it looks oversold post special.
Still have some cash but (as always) the trick is finding the right opportunity.
GLA
Hey Scored, he looks a bit scruffy but he is ranked 3rd for UK fund managers, of course I am 2nd (and more handsome), but he really is well worth listing to!
Have a good evening bud, lets look forward to some great news next week.
ALB
Hi Scored, I have spent an hour today listening to Nick Train on one of his investment trusts, well worth a listen just for his outlook (I don't hold the trust but I respect the portfolio manager and hold 3 of the top 10 holdings direct) link below is a YouTube video but not worth watching as it's just the fund manager talking.
There is one key phrase I have heard several times now in the last month (today also from Nick Train), we are about to experience the "roaring 20's", not only as the economy rebounds but also as new efficiencies are found from emerging technologies.
While I rate DNL as a great business, with a good management team and is a good investment, once again I feel the current investing theme isn't really in our favour - I get the impression people are now looking for value and cyclical opportunities. I'm certainly not saying DNL wont do well (it's certainly good value), however, the current situation is the opportunity of a generation - I believe history may well look back on this as "the roaring 20's" - time will tell.
Nothing has changed on the DNL opportunity (except that doctors will soon be able to accelerate prescriptions of Alkindi and Chronocort), but much of the remaining market has changed.
This is partly why I have been upping my holdings of UK investment trusts, another part of the reason is that I just don't have enough time to properly research many companies.
You said you were overweight already and looking to invest another 15k, hopefully this may be some food for thought.
https://www.youtube.com/watch?v=GZb6RRd9wok
Hi Scored, DNL is still a hefty chunk of my portfolio (well over my new rules on maximum holding size - which is a chunky 10% max).
To gain some diversity, I have been looking at a few UK investment trusts, eg Edinburgh. It's a bit boring but we expect some UK recovery and personally I cannot take any extra DNL. That said, I am confident.
I have been looking at the 2020 approval figures for CHMP, it's actually quite encouraging;
Applications for EMA approval = 96
Approvals = 94 (98%)
This year to date;
Applications = 20
Approvals = 20
We should take some comfort in the fact that the EMA are in the business of approving safe and effective drugs and that DNL is a well run company with experience of this process and plenty of positive data on Chronocort.
I have also noticed there are two different levels of approval, including "conditional approval" (The approval of a medicine that addresses unmet medical needs of patients on the basis of less comprehensive data than normally required. The available data must indicate that the medicine’s benefits outweigh its risks and the applicant should be in a position to provide the comprehensive clinical data in the future.)
Again, I think we should take some comfort not only in the extended set of data from DNL but also from the published positive outcomes (e.g. pregnancies). I believe we should exceed the minimal requirement for "conditional approval" and we should receive the full "marketing approval".
We are in the final stretch, IMO, this will vindicate DNL for the previous rejection and hopefully create a sustained price movement.
GLA
https://www.edisongroup.com/publication/improving-treatments-for-endocrine-disorders/29037