Amryt Pharma Share Discussion Threads

[diamondstar1] 29/10/2020 13:31

Paps - expect lots of fireworks on Monday, after Amryt discloses the full EASE results at the EADV Dermatology Meeting - this weekend. It is at the EADV, where they should get press coverage.

[ultrasharp] 29/10/2020 12:50

Disappointing share price rise on AIM today after such a good RNS. Generally poor market conditions don't help. Hopefully AMYT will perform better on Nasdaq this afternoon.

Definitely not a time to sell. I believe the AMYT share price will continue to climb over the few weeks. Don't forget more good news on the way including likely good Q2 figures issued next week.

ATB PAPILLON

[timbo003] 29/10/2020 11:48

Don't forget that Amryt will be presenting at the Proactive (virtual) one2one event this evening, registration details are below:

[timbo003] 29/10/2020 11:44

Nigel

Fine details below

The cash will be distributed based on around 53 million shares in issue at the time, so there will be 53m of each CVR in issue

[waterloo01] 29/10/2020 11:25

Triggers are EU approval, FDA approval and finally based on sales. So 3 events against 3 CVR's

[timbo003] 29/10/2020 11:22

Nice to see the meat on the bone after the initial announcement on Sept 9th

Agree diamondstar, those CVRs look more valuable this morning. I suspect if they were tradable the value of a package comprising the three different CVRs would have increased from around 30p/three CVRs to around 60p/three CVRs (their maximum value if all three CVRs paid out would be about 122p/three CVRs)

[richpassi] 29/10/2020 11:20

I was happy to see them too ;)

[gnnmartin] 29/10/2020 11:14

Is there a nice brief summary of what the CVR's can expect and what the triggers are? The only document I've found runs to nearly 70 pages, and I lost interest attempting to find out anything by reading it.

[diamondstar1] 29/10/2020 10:56

Richpassi- my hat off to you for dabbling in biotech shares. Sometimes, I have difficulty myself interpreting some trial results, and I have been working in this field for a long time. Looks like some massive buys in Amryt this morning, over £2 million! Shows confidence in the results.

[diamondstar1] 29/10/2020 10:18

Bageo - a clinical trial does not have to meet statistical significance for Secondary Endpoints, as a trial is usually powered to detect significant effects in the Primary Endpoint. It’s a nice to have. Since the treatment effect in the Primary Endpoint is clear i.e. 12.4%, I believe that Regulators (FDA, EMA) will only want to see a trend for improvement in the Secondary Endpoints. The reverse would be true if the treatment effect were smaller e.g. 5-7%. Regulators will be more concerned about secondary endpoints in this case. All the best Amryt shareholders - do hold on tight to your CVRs as these might be of value, given the recent disclosure from Amryt today!

[charlie_munger1] 29/10/2020 10:12

So is the efficacy percentage 12.4% then?

[richpassi] 29/10/2020 10:08

Thank you diamondstar, as an old car mechanic I couldn't make head nor tail of the figures ......very much like new cars these days !!! Lol

[diamondstar1] 29/10/2020 09:51

41.3% complete would healing at Day 45 in Episalvan arm vs 28.9% in placebo arm. That is effectively the Primary Endpoint in the study, suggesting a 12.4% difference in treatment effect. As per my previous posts, I believe these results will be well accepted by Regulators since there are no approved therapies. The fact that there were statistically significant differences in pain score, suggesting alleviation of pain in the Episalvan arm, is a bonus. Amryt share price should target 250p levels; this latest information should increase the chance of drug approvability.

[bageo] 29/10/2020 07:57

Reads well and nice to have the detail. It seems clear that there are major advantages but also a few aspects where the benefit is less clear cut. Does anyone have an informed opinion on how common it is to have trial results where headlines are clear cut benefits and other aspects are less statistically significant. I don't have the knowledge to judge that.thanks

[alphabravo321] 29/10/2020 07:17

So Diamondstar, would I be right in saying the treatment effect is circa 8 percent?

[richpassi] 29/10/2020 07:05

Positive Results ;)

[ultrasharp] 28/10/2020 20:09

Yes, Bermudashorts. The ADS's price on Nasdaq has recovered going by the last trade price. Volume still low.

ATB PAPILLON

[bermudashorts] 28/10/2020 19:11

Yep markets have been dire today and AMYT holding up reasonably well compared to some in the sector.

[ultrasharp] 28/10/2020 18:18

AMYT weakens on Nasdaq today on very low volume. Shares worldwide along with other asset classes, such as gold and cryptocurrencies, all well down today on COVID 19 fears.

ATB PAPILLON

[alphabravo321] 25/10/2020 09:12

So its all about the treatment effect percentage

[diamondstar1] 24/10/2020 22:48

Hi Bermudashorts,

Great point you have raised.

I believe that the bar will be as low as the Partial Thickness Wound (PTW) indication, simply because there are no current approved therapies for EB, similar to when Amryt obtained EU Marketing Authorisation for PTW. The wounds that EB patients get, after all, does resemble Partial Thickness Wounds.

With regards to Amryt believing whether they have good enough data to file an NDA, I personally believe that Amryt have invested so much time, effort and resources into Episalvan for EB, I feel they really have nothing to lose by filing an NDA, irrespective of whether the placebo-adjusted efficacy is 6% or 12%. There is really no precedence or benchmark ie drug approvals or lack approvals in the EB space based on efficacy data. I do not believe safety will be a concern from Regulators. Remember that if their NDA filing is accepted by the FDA, then they will be granted the Priority Voucher worth $70 - 100 million. They do have an advantage of being the first company to meet statistical significance for Primary Endpoint in a Ph3 EB trial.

[bermudashorts] 24/10/2020 21:20

diamondstar,

Thanks for that, but don't you think that most investors will simply be looking to see whether Amryt believe the data is good enough to file an NDA and more importantly for the FDA to approve that NDA?

The trouble with making direct comparisons with the partial thickness wound results it that it assumes the approval bar is set at the same level and I'm not sure that's the case.

[charlie_munger1] 24/10/2020 20:54

Thanks for the great insights diamondstar1 and papillon

[diamondstar1] 24/10/2020 18:09

Looking at previous Episalvan Ph3 trials in Partial Thickness Wounds, the mean improvement in Wound Healing was 9.3% in one study and 5.6% in another study.

If the EASE study in EB shows that there is a >10% improvement in wound healing, I believe that Amryt share price will rally. If it is around 5%, I believe share price will have a downward bias (as marginal efficacy will not be viewed positively since secondary endpoints were not met).

Another possibility is a neutral result - ie efficacy around 7.5%, which is the average of their previous PTW Ph3 studies. All the best shareholders in the upcoming EASE Ph3 results next weekend!

[charlie_munger1] 24/10/2020 15:58

Your theory makes sense, hopefully that's the case. Would they be making a big song and dance about these results isn't in some way to try and put pressure on the FDA and the Europeans to approve the gel? Probably not, as them people will look at the efficacy results and nothing else you'd imagine. They'll obviously acknowledge that there's no other treatment on the market currently.