Member Info for HunSen

Fantastic news all, well done to those who held tight - lets hope we see a big increase on the open.

I just brought 3000 shares, 3 seconds after the bell!

My guess is that they may have decided to announce when both US and UK are not trading - this affects Eton and Diurnal shareholders. So that could mean a 7AM RNS - but then it could mean a late this evening announcement by the FDA.

GLA.

Another article, nothing new really;
Another catalyst coming its way is the FDA decision on Alkindi Sprinkle, a taste-neutral granule formulation of hydrocortisone, expected on September 29, 2020.

Alkindi Sprinkle is proposed as replacement therapy for pediatric adrenal insufficiency (AI), including congenital adrenal hyperplasia (CAH) in infants to patients less than 17 years of age. Eton acquired U.S. marketing rights to Alkindi Sprinkle from Diurnal Group plc (DNL).

The market opportunity for Alkindi Sprinkle in the United States is estimated to be greater than $100 million annually. The product was approved in Europe in 2018 under the trade name Alkindi and is marketed by Diurnal in select countries throughout Europe.

Morning,
something to read while you are waiting;
https://www.pharmalive.com/fda-action-alert-aquestive-eton-and-mesoblast/
Good luck today

We should hear during the day tomorrow, I have signed up for FDA email alerts.

DMcG54, I was thinking along the same lines, also, during that time I found it very hard to buy any more at the lower price, so perhaps the mms are trying to shake the tree a bit.

Currently no quote to buy.

MasterRSI, I sometimes see additional positions on Level 2, this morning I saw positions at 104p and 120p - what does this mean? Are these retail limit orders?

What do you mean? There are seven offers on level 2, should be available. Try in multiples of 1500 shares

Scoredagain, yes, it is a binary event, either good or bad, very little middle ground.
That said, it is a re-formulation of an existing drug (i.e. a new, precise delivery method and taste neutral), so I believe there is very little risk.

Hey Scoredagain,
what time of day did it pass FDA? Just thought this may not be 7am news UK time.
Well done on the other result.
GLA

There are investors who will not buy on "speculation" of drug approvals, although it is being said that Alkindi Sprinkle has a 90% chance of approval (perhaps that is Eton being cautious?). This drug is at the last hurdle and seems to be the only runner - I believe it is safe.
The up side of this is they will buy the news when approved and when things are more certain - they will be prepared to pay more and this will give the price an added boost.
I purchased more yesterday and I think I am at my maximum exposure now - I would like to buy more but that would be reckless (need to stay diversified).

I don't use twitter, can anyone post here?

Well, there are only 3 clear business days until approval - this is close, but they have always said it could be early.

GLA

Yes, we are also above the year highs.

How high can it go?

Yes, it is looking good, rising volumes, rising price, even against general market volatility.

We are less than a week until the planned PDUFA date, I believe people will start to buy into the weekend.

GLA

Very few shares in the blue today, shows the potential for DNL.

Another interesting report and all seems to be going to plan.

One question on the valuation - when does this apply? Compared to US peers, DNL also appears to be undervalued. It seems all commentary is pointing to a significant upside.

Hi Chester,
I think the FDA isn't a done deal yet (but, I read recently that the FDA said "we need this drug" or something along these lines). If you look at the long term share graph, you can see an FDA rejection, I believe there was a statistical error in that FDA submission, but perhaps investors have a memory of this.
In addition, it is not so much a new drug, but it is a new delivery method for an existing drug - so there should be no real reason for the FDA to reject this.
It is true that Richard Griffiths has been a seller, but he does manage a fund and perhaps the % holding became too high as the SP has increased - he is a bit of an unknown. Or perhaps he is looking at other opportunities.
I have increased my holding in the last year and I have confidence in this company.
FDA approval will be a huge step, putting the company on course to be profitable by 2022.

The CEO is presenting online tomorrow (look at threads further down for the link).
ALB

Hi MasterRSI,
could you please post the source URL for the Panmure comment? I wonder why these comments aren't reported on LSE? The broker ratings are very old.
ATB