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That's a shame 3 long term shareholders being forced to sell.
If they hadn't bought Chiasma I might have held but earning per share are going to be under pressure until the get MYCAPSSA up and running and generating revenue.
Bermuda, that's a wonderful gesture and I very much share your hopes for swift Filsuvez approval and developments of other treatments for EB. Wishing the very best luck to you and Jim and to all remaining holders here going forward.
I've also reluctantly decided to cut my loss here and sold my holding. Having done a bit of research, I don't think the FDA extension necessarily signifies anything good or bad for Filsuvez, but having shouldered a loss elsewhere this week, I simply can't risk a heavier hit than I've already taken right now. All the best.
Had been dithering about whether to convert to ADRs and today's news has made my mind up. Reluctantly I've also decided to move on. Will keep a close eye on progress and wish longs here all the very best. I've been investing in bios for several years and researched companies involved across a wide range of disease areas, by far EB has been the most harrowing and really is the worst disease you've never heard of. So most of all I hope that Filsuvez is approved without further delays and that it's the first of a many new approvals for for EB.
I'll be donating a percentage of my profits here to Cure EB and DEBRA UK.
I think you overstate Lara's importance to AP103. Lara moved on well over a year ago - Sep 20. If Lara going meant the end of AP103, they've had 15 months to break it to us.
Amryt included several slides on AP103 in their corporate presentation in July this year, long after Lara had gone, and showed multiple ongoing activities on the work stream with clinical trials in 2022. No one is pricing AP103 into the SP at this stage but it should be pretty clear that the company is still working on it.
Btw Good luck all.
Was doing some DD as to whether I should hold but decided to nite the bullet and move on.
I see Lara Cutlar the University College Dublin Scientist that had a big role in the development of the Gene Technology has moved on.
Amryt hired her in 2018.
https://www.linkedin.com/in/laracutlar
One thing that is hard to understand is why the FDA left it so late to declare that the additional data is a major amendment of the NDA. It's not like they just got this data recently. I figure that they are probably being very cautious with this review. A lot of the trial data points are marginal so they need to be absolutely certain about statistical significance before approval.
Bermuda - I agree that it is most likely positive and could be for broader labelling. Not great news for the CVRs but not negative news either.
onceaday - some excellent posts, thanks.
joxer - you have to assume that in view of the fact Amryt submitted the data, they believed they were positive and supported their case. Impossible to guess what it's about but could well be in respect of broader labelling rather than a yes/no decision for approval.
The delay is "to allow time to review additional analyses of data previously submitted by Amryt" as this additional data submitted is considered to be a major amendment of the NDA. So, the question is what does this additional data show - positive or negative? Amryt could provide an update on the specific additional data that is being reviewed.
The effect on the CVR's
· FDA approval
o US$35,000,000 upon FDA approval
o 100% of the amount due if approval is obtained before December 31, 2021, with a sliding scale on a linear basis to zero if before July 1, 2022
· EMA approval
o US$15,000,000 upon EMA approval
o 100% of the amount due if approval is obtained before December 31, 2021, with a sliding scale on a linear basis to zero if before July 1, 2022
So, based on the above, and the new PDUFA date of Feb 28, 2022, I reckon that means a 30% haircut on the CVRs.
FDA NDAs are risky period! I wouldn't say that Amryt is a more risky hold now than prior to this extension. If FDA were not supportive of the NDA, they would have simply issued a complete response letter (CRL) which would have been a disaster. Instead, they have asked Amryt for more data. I read that as broadly positive - especially if you look at similar PDUFA extension outcomes.
Yes no way this is anything other than terrible news. Best case a 3 month delay to the new revenue…worst case no approval, which must now be considered more likely than pre the RNS. The new timeline also complicates it for those who didn’t want to be on Nasdaq. Anyone who (like me) topped up on ydays fall must feel pretty unlucky!
Well now its a risky hold.
Potentially no Filsuvez revenue
They just paid top $ for Chiasma that has no revenue.
Now I'm like Natalie Imbruglia TORN
So now yesterday's announcement makes sense!
This is disappointing but at least it's not a complete response letter (CRL). I guess the FDA had a look at the data and decided they wanted further analysis - extending the PDUFA date is not that unusual. Ironically, the delay will benefit Amryt because they will potentially pay out less to CVR holders. I am more hopeful that the EMA will approve given that they have already approved for partial-thickness wounds.
Well Jayne looks like we're all going to be underwater soon here.
and our CVR's are looking more like monopoly money.
Spoke to HL, yesterday, and a polite chap informed that they should know more early next week on how to proceed with the deposits, about which they will probably inform their AMYT holders; as soon as I hear, I’ll update you.
ok got it...my mistake
Cookie45. There is a little potential hassle with the transfer and some exchange rate implications when selling the shares but other than that I don’t think there is anything to worry about. I just looked up a quote for Amryt ADSs which was $11.20 and that neatly converts to the Aim share price x5 as it should do.
Hi....the move makes absolute sense, simplifying things and saving costs. I just want to make sure that the value of my investment is not reduced during the transfer. Is the current value of my holding converted to $ and the respective amount of ADS's issued? or am I simply issued 1 ADS for every 5 Ordinary shares? If the latter 1 Ordinary share = $2.22/5 which equals 0.44cents per ADS share and given the current share price of 0.11cents ...i lose 3/4 of my investment which i am sure isnt the case. Can anyone clarify?
Naw I wouldn't think Krystal and Amryt have enough synergies,other than Filsuvez.It doesn't fit in with Krystal's business model imho.
+
I don't think Krystal can afford Amryt.
Probably more to do with a bad trial or maybe Krystal might be getting acquired and its a tree shake knowing how corupt these markets are.
Are you thinking what I’m thinking?
I see Krystal Biotech is down almost 20%.
I was considering buying more at 1.55 but I decided I have too many already.
Is that a 1.50 triple bottom?
Would be nice to finish up 10% fir a change.