Amryt Pharma Share Discussion Threads

[diamondstar1] 16/3/2018 12:20

Pottermagic...I understand your frustrations (as all of us are in the same situation as shareholders).

But just to let you know that when they mention ‘interim analysis’, they also mean that the data will be analysed and disclosed. I am sure it is not a play of words. The interims will be provided in Early Q4 2018, my guess around Sept/Oct 2018. Hence, it will be a 6 month wait, and if this is positive, then this will bring value to Amryt if we reach that milestone.

[pottermagic2310] 16/3/2018 11:50

Perfectly... expect nothing of any value until 12 months time from the AP101 perspective.

Meanwhile there's been a classic misdirection... "Oh, by the way, something different, look at this, over there, new possibilities" ... away from the AP101 delays.

It's simple what's going on and it means we're stuck locked-in right now waiting for:

a) new News regarding the new Ventures being looked at
b) delayed News regarding the continuing AP101 Trials

[bazworth] 16/3/2018 11:49

Would recommend that you all listen to the video interview. Cannot post the link here but easy to find on our well known search engine. Just type in AMRYT!!

I’m as relaxed as a relaxed person can be!!

[papillon] 16/3/2018 11:27

You are wrong again, Pottermagic. Fake news! Can't you read?

This is what yesterday's RNS states:

"Conclusions

These changes will result in a slight delay of the interim analysis which the Company expects will be complete in early Q4 2018, with read out of top-line data from our AP101 Phase III study in Q2 2019.

The incremental cost of these changes is expected to be approximately EUR1 million. The unblinded interim analysis will be conducted by an independent data-safety-monitoring-board and will result in three possible outcomes:

-- continue the study with no change to sample size, which would reflect conditional statistical power of at least 80% or better;

-- increase the number of patients in the study to maintain an 80% conditional statistical power;

-- or discontinue the study for futility.
The unblinded interim analysis read out potentially represents a significant milestone for the Company."

The unblinded UNBLINDED INTERIM ANALYSIS due in early Q4 2018 will determine whether, or not, the EASE trial is FUTILE. That unblinded interim analysis, which will determine whether AP101 is successful, or a complete waste of time is now delayed until Q4 2018. It was ORIGINALLY forecast to be in H1 2018. Since diamondstar reckoned March 2018 by the earliest that means WHETHER THE EASE TRIAL IS A WASTE OF TIME, OR WHETHER TO CARRY ON, THAT IS DELAY OF 6-7 MONTHS.

Is that Okay Einstein? Can you understand that?

PS. That doesn't mean the company wont further delay the unblinded interim trial result. I can't predict the future.

[greendragon777] 16/3/2018 11:21

I read it differently Pottermagic. The interims have changed from H1 to early Q4 (hopefully October) so one could actually see this on the lower end as a 4 month delay going from June to October or 7 months at the higher end.

I see it as a 5 or 6 month delay and if it's the difference between a positive readout and a negative one then it's simply a no brainer. Yes things may go very quiet over the next few months but these things take time. If you want to invest/speculate/gamble on something with much quicker results consider Cryptos.....it moves at breakneck speed. But the same goes for the losses, I'm nursing some wounds on that front right now! :-(

[greendragon777] 15/3/2018 23:39

I agree Paps that the share price will probably slide given the timescale has been pushed down the road by 6 months. Unless there is another significant announcement I can't see it going up considerably from here until the interims or the run up to them.

It's a nice feeling though that the odds of success with the trials have effectively increased somewhat. They were pretty decent odds to begin with so one would have to be very optimistic now for a successful outcome. AP101 was always the big bet on AMYT so it's defo worth the wait for an increased chance of success.

Looks like we might be catching a good few zzz's between then and though Paps! :-)

[greendragon777] 15/3/2018 23:33

Thanks Diamondstar, very helpful info. If the patients with the EB Simplex condition are now being excluded from the trails does that mean they cannot be treated with AP101 if approved in the new trial?

I understand they are less likely to need/want the AP101 treatment if it's not necessary going to make a major difference but it would be good to know anyway. I'm guessing that there may different levels of the simplex condition and perhaps some would chose to use the treatment albeit that the improvement may not be as profound as with the patients that have the more severe condition.

[papillon] 15/3/2018 23:04

I didn't expect today's update to issue the AP101 interim trial results, however the can has been effectively kicked down the road by around 6-7 months, because I was expecting the interim EASE results this month/next month (in line with diamondstar's analysis) and now it looks like they wont be issued until probably October 2018.

The UPSIDE is that the Episalvan EB trials have a greater chance of success now that the EB Simplex patients are being excluded. Presumably the AMICUS data on the Zorblisa phase III trial led to the change in the Episalvan phase III trial method. I wonder why AMICUS were so generous? They must have an ulterior motive, IMO.

The DOWNSIDE is that the potential market for Episalvan, for treating EB, will be lower. How much lower is anyone's guess, but diamondstar guestimated it will be reduced by around 30-50%. That means a potential annual market of 650m - 900m. He argues it will be less than the 70% that one would expect (since EB Simplex sufferers account for 70% of the total of EB sufferes), because the remaining 30% suffer from more extreme conditions and so they would expect to need more treatment time than the EB Simplex sufferes. Make sense to me.

I sold 20% of my shares @ 19p today. I'm keeping the remaining 80% because though the results are going to be delayed by around 6-7 months (what's 7 months in the scheme of things?). Why am I continuing to hold? I think though the potential market for AP101 might be halved, I do believe it has a greater chance of success. Also Lojuxta sales are growing fast and there is hope of another, similar, licensing deal. I also believe the AMYT BoD and management are on the ball and react quickly and proactively to changing circumstances.

[papillon] 15/3/2018 22:20

You're wrong yet again, pottermagic. Read up on diamondstar's excellent posts. He expected the FINAL, definitive, results to be announced around 6 months after the interim results. Around September/October 2018. That tallies with the previous forecasts from AMYT (read up on the previous RNS's). So the Final, definitive, results are being delayed by around 6-7 months from diamondstar's and AMYT's previous forecasts if the company is now forecasting them in Q2 2019.

Hence the modified trial results (both interim and final) are being delayed by around 6 months, NOT your completely erroneous 12 months!

This is what the Final Results RNS dated 30/3/2017 states:

"The Company achieved important milestones in 2016 and we remain confident of continuing significant progress over 2017. Our Phase 3 clinical trial for our lead product AP101 has just commenced and we are optimistic of receiving top-line data in H2 2018. In the meantime, we will have the results of our interim analysis which will be an assessment of the progress of our study by an independent data safety monitoring board. We expect to have the results of this assessment in Q1 2018"

So pottermagic it's there in black and white. The final definitive results were never expected now! Okay? They've been delayed by at least 6 months using diamondstar's recent forecast, NOT by your erroneous 12 months!

[papillon] 15/3/2018 19:08

I watched the Wiley Sky News interview on youtube. Basically just repeats what was in this mornings update concentrating on the gene therapy licensed in yesterday and Lojuxta revenue growth.

Still going to sleep for another 7 months. I'm doing my Rip Van Winkle impersonation!

[papillon] 15/3/2018 18:54

What did he say, Icebreaker?

Well we will have to wait at least another 7 months for the EASE interim trial results following on from the announcement in todays RNS that they are now scheduled to be released early in Q4 2018. Ah well back to sleep for 7 months!!

[icebreaker] 15/3/2018 18:46

Wiley on Sky NEW’s now.

[superbobtaylor] 15/3/2018 17:19

I read it as they are simply excluding the simplex patients as they have a fair chance of healing without treatment so without a significant blind cohort it will adversely affect the accuracy up the results.

Been following this one for a while without buying. Will be waiting a while longer.

SBT

[papillon] 15/3/2018 15:48

Was this your buy, Filterwest: 8k @ 18.96p timed @ 15:29 pm?

[filterwest] 15/3/2018 15:32

Bought some more.

[papillon] 15/3/2018 15:29

Many thanks for that, diamondstar. I've sold some of my AMYT shares today. I'll probably hang on to the rest for the longer term (depending on the chart) and stick them in the proverbial bottom drawer. I might buy those shares back again nearer the EASE interim trial results in 6 months time and if the price is lower by then.

Obviously if they managed to secure another Lojuxta type licensing deal before then that could provide a fillip to the share price

The reason I've decided to keep most of my AMYT shares is because the company appears to be well managed, with a proactive management and the company is currently well funded with a growing revenue stream from Lojuxta.

PS. I expect the share price to drift down to re-test the circa 17.50p support.

[diamondstar1] 15/3/2018 14:57

The reason for this is the patients with the more severe forms of the disease ie JEB (Junctional Epidermolysis Bullosa) and DEB (Dystrophic Epidermolysis Bullisa) are the ones who are more likely to want to participate in a trial as they are seeking a treatment that can improve their quality of life.
Therefore, EASE trial will likely have much more JEB/DEB vs. Simplex (EBS). My estimate is 70:30 in terms of enrolment ratio at present.
Similarly, the market for EB products would also be weighted towards JEB/DEB. Hence, while they only consist of 30% of patients, they will require much more in terms of resources (anywhere between 50-70% of total EB market, is my initial guess, but this will require real data to support such an analysis).

[rollthedice] 15/3/2018 14:57

^ Oh well s##t happens :) I don't hold a huge number of AMYT so will just sit on them to see how it all pans out.

[papillon] 15/3/2018 14:54

You could be right, greendragon and AMYT's 1.3bn potential target didn't include too much of that 1.3bn for EB Simplex, since as you say they are only increasing the trial numbers by 20%. Perhaps the analysts will come up with a more credible, generous, potential market value target than my guesstimate of 400m Euro's. Perhaps one only reduced by 20% to 1bn Euros? We'll have to wait and see.

Yes I think you are viewing "through rose- tinted specs", rollthedice.

[rollthedice] 15/3/2018 14:37

I didn't read the RNS that the market for AMYT for EB would exclude EB Simplex but that trial would focus on the more severe cases so the efficacy of the treatment would be more easily demonstrated... if it works on the complex cases, the faster healing EB Simplex cases would be a doddle.

Have I got that wrong, maybe viewing through rose-tinted specs?

[greendragon777] 15/3/2018 14:35

Surely it won't equate to that Paps....in that case it would reduce the whole value of AP101 by a similar amount. Perhaps we will find out from the meeting assuming that someone will be asking these questions.

Begs the question though how they are only increasing the patient numbers by 20% if potentially 70% had the simplex form but I know absolutely nothing about how the process works.

We might need to ask Diamondstar (yet again!) about this! 😊

[papillon] 15/3/2018 13:43

EB Simplex is the most common form of EB and accounts for approximately 70% of people suffering from EB.

70% of 1.3bn Euro's (AMYT original estimate for value of the total EB market) is circa 900m Euro's. If the removal of EB Simplex does correspond to a circa 900m Euro reduction in the total potential market value for Episalvan for treating EB (it might not be such a straight forward correlation) then that leaves the potential EB market value for Episalvan to target as circa 400m Euro's. Still significant, but nowhere near the blockbuster original 1.3bn Euro target!!!!!!!!!!!!!!



PS. On further reflection, greendragon, perhaps AMICUS gave permission to AMYT to inspect the Zorblisa data because they are no longer interested in treatments, such as ointments like Episalvan, because if EB Simplex sufferers are removed from the potential EB market, the potential is too small to interest them?

[bazworth] 15/3/2018 13:02

This is what I like, especially the “series of agreements”!!

We have ambitious plans for the remainder of 2018 and we look forward to announcing a series of agreements in the months to come. This is a pivotal year for Amryt and our focus continues to be on ensuring that we are delivering real change for people with rare diseases across the world. I am proud to say we are delivering on our promise."