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I note the Nasdaq listing has now also been added to HL which states it is available for ISAs / SIPP. However the message I received states the following;
Important information for ISA holders only
Following the delisting, both the ordinary shares and ADSs will no longer be an ISA qualifying investment and will need to be removed from an ISA. If you hold ordinary shares or ADSs in an ISA after the delisting, we’ll write to you again with your options.
Maybe the message is not correct but I made my decision based on that - I wouldn't be surprised if others do the same and looks as though there has been a host of sales possibly of the back of HL's note today - i couldn't get a live quote to sell initially either. There could well be a drift in price so I suspect I'll have time to review my options and possibly buy back in nearer to the transfer date.
Wasn't intending to cause confusion and hope I'm wrong as will consider adding again at some point.
That wasa in reply to hope_n_glory
NOT TRUE.
I have just given instructions to convert my shares held in an ISA with HL to ADR's.
Thanks - for completeness, my shares are held in my SIPP and HL made it extremely easy to transfer them to ADSs. Just log in through the web rather than your app, go to corporate actions for Amryt and click transfer.
In case this impacts others. Just had to / decided to sell my holding as HL informed me that following the delisting shares won't qualify for an ISA holding. Rather annoying as there had been no mention of that to date and I planned to just transfer and ride out the moves and instead have realised a loss from a profit before the announcement. Could have moved it out of my ISA but that's where I wanted it held.
Jim. I think the science is promising but I am not buying back in now. Given that there should be fresh data in January, posssibly the xmas lul might be a better time -.and we will know more about the effects of Omicron by then.
Once.so u think Krystal is a bargain at 70 bucks?
I'm very cautious when investing in companies with no revenue.
I see GS are now one of the underwriters,that's generally a good thing.
My broker HL still awaits more information on the delisting before it communicates on converting our shares into ADRs.
True. The last time the Chairman made a large (LSE) purchase the price jumped but I guess US investors are not impressed.
The price will likely move sideways until after the AIM delisting (Jan 10). Unfortunately, some LSE shareholders cannot hold the ADRs and so will be forced sellers on AIM.
It's does show the lack of interest in this share
Definitely, sure look at the market for Botox.
It probably one I missed.
Couldn't put the trigger now.
Jim
Yes the CF trial results must be hotly anticipated by CF sufferers - let's hope the outcome is just as positive as for EB. IMHO, the real money-spinner could be Jeune Aesthetics. Krystal's aesthetics subsidiary is due to announce phase 1 data in early 2022 for "KB303, an innovative, investigational gene-delivery therapy designed to enable local, full-length elastin production in the skin". Ask yourself how much is spent worldwide on skin improvement products (that probably don't work). If KB303 really does rejuvenate the skin through gene therapy, it will be an undoubted winner!
I suspect the Chairman's purchase leaked last night given the NASDAQ after Hours price
10.39 +0.83 (+8.68%)
After hours: 07:25PM EST
Sorry Jayne.
Well done once.I was looking at Krystal but got greedy.
Also because of their cystic fibrosis candidate as Ireland have the highest levels in the world of it.
The Krystal Phase 3 results are certainly grounds for optimism in the EB community. However, bringing novel gene therapy to market is likely to be significantly more fraught than an ointment made of birch bark and sunflower oil. I would expect the regulators to be heavily focused on safety and it's worth noting that the sample sizes in the Ph2 and 3 trials are relatively small. According to clinicaltrial.gov, Krystal is running a study entitled "A Long-term Treatment With B-VEC for Dystrophic Epidermolysis Bullosa" which won't read out until Dec 2022. This is probably an insurance policy against a safety knock-back from the regulators.
I did buy a few krystal last week and sold out on US market open this morning. It's almost covered my Amryt loss!
Before you dive into Krystal, it's worth noting that they are being sued (and countersuing) regarding the use of the core technology (the Herpes Simplex Virus) in their platform which further complicates the outlook. https://seekingalpha.com/article/4468950-krystal-biotechs-legal-risk-view
Jim, I've haven't heard about Vyjuvek from the contacts I have within the UK EB community, but then I've not been as involved since my family member passed on. Dystrophic EB sufferers already carry a high risk of developing cancer and my understanding is that gene therapy itself carries an enhanced risk, which is why my money was (literally) on Filsuvez.
However... Vyjuvek doesn't seem to be an insertional gene therapy so I'm wondering whether the risk has been deemed to be much lower with topical application? It's a fascinating area and thanks for the prompt as it's something I should really research further.
From my own perspective I can't see how the FDA would compare one against the other simply because of the difference in approach/risk.
Krystal's NDA won't be submitted until next year and likely well after Amryt's revised PDUFA date. FDA will only get to review the data upon submission.
I know at 1 stage a few years ago AP103 was only a few months behind and it still hasn't entered the clinic.
Krystal might get approval before Filsuvez its share price is up over 100% today.
Not sure if the FDA would be comparing the results of the 2 trial against each other.
Jayne what do you think?
https://finance.yahoo.com/news/krystal-biotech-announces-positive-topline-120000999.html
Well I don't know if it's only a delay because of a manpower issue why are they looking for more data?
Plus no one is talking about this.Whay are the 'Major Objections' the EMA have.
The European Medicines Agency (“EMA”) review process for Oleogel-S10 in EB is ongoing and Amryt is in the process of responding to the remaining Major Objections in the List of Outstanding Issues sent by the EMA. The Committee for Medicinal Products for Human Use (“CHMP”) opinion is now expected in January 2022.
After reading some of the comments here I believe this Stifel note should be known more widely:
"Stifel view: The FDA appears to be extending review times on multiple new drug applications.
A similar three-month delay was received by Calliditas (covered by our colleague Annabel Samimy) for its drug Nefecon in September 2021, even though it also had priority review status.
We believe if the FDA had decided that Filsuvez was not approvable at this time it would have issued a complete response letter (CRL). This three-month delay therefore does not impact our view of the high (95%) likelihood of product approval.
We had previously assumed first sales of Filsuvez in 2022 and leave these forecasts unchanged, expecting sales of US$42m in 2022Ewith sales reaching US$342m in 2027E."
Whilst unwelcome this is a delay & not a rejection. The FDA have requested some more limited info / clarifications, that is all.
I now put the chance of approval at somewhere north of 50/50
The link is to a ********** (VxMkt) comment
https://www.**********.co.uk/articles/amryt-provides-update-on-regulatory-review-process-for-oleogel-s10-888baa4