Amryt Pharma Share Discussion Threads

[bazworth] 09/9/2020 08:15

Bermudashorts, thank you. I think I get it!

So good of you to explain

Good luck

baz

[bermudashorts] 09/9/2020 08:09

bazworth,

The primary endpoint of the trial was the proportion of patients with first complete closure of the EB target wound within 45 days of treatment. So the trial demonstrated that a statistically significant greater proportion of patients being treated with AP101 had complete wound closures at 45 days compared to the placebo group.

The secondary endpoint was time to first complete closure of the EB target wound and this endpoint wasn't met. You might think that the 2 endpoints go hand in hand but the big difference between the two was the timing - the 2nd endpoint was measured all the way to 90 days.

This mirrors the data seen in the Amicus trial. One of the lessons learned from that trial was that timing of the endpoints is crucial. The Amryt trial is showing that patients on AP101 were quicker to heal but that by day 90 the placebo group were also healing and there wasn't a statistically significant difference between the 2. That's not to say that when they drill down into the data they wont find differences between subpopulation groups.

The FDA will therefore be presented with findings that show AP101 results in quicker healing for a very painful disease for which there has never been an approved treatment.

Hope this makes sense.

[bazworth] 09/9/2020 07:40

Thanks Bermudashorts, I understood those issues but does the news confirm that all is as good as it possibly could be? Thanks in advance!

I’m gobsmacked to hear this so soon....

[alphabravo321] 09/9/2020 07:38

Here comes the whoooooosh??

[bermudashorts] 09/9/2020 07:36

bazworth,

It's fantastic news - primary endpoint met and Amryt are applying for FDA approval.

[bazworth] 09/9/2020 07:35

CVA’s, forgot we had those rascals.....

[waterloo01] 09/9/2020 07:30

Those CVA's suddenly look rather valuable.

[waterloo01] 09/9/2020 07:21

Fantastic news.

[curnic1] 09/9/2020 07:11

Nice RNS to start the day.

[bazworth] 09/9/2020 07:11

WOW! This looks brilliant although I have no medical knowledge so would appreciate comments from those who better understand. Great for those suffering from EB too.

[bermudashorts] 08/9/2020 22:15

Certainly going to be an interesting period, would be fantastic if EB results are 100% positive and every endpoint is met with overwhelming statistical significance. Given the population mix, the nature of the disease and the possibility of a high placebo response, it may not be as black and white as a success or fail situation. There may be subpopulations that responded better than others or certain endpoints that are met/missed.

The FDA are acutely aware of the need for EB treatments together with the difficulties in designing clinical trials and defining endpoints to provide proof of efficacy. Last year they produced a guide which can be downloaded from link below. It places far more emphasis on patient reported outcomes which can only be a good thing and they are clearly keen to see EB patients benefit from new treatments - well actually any treatments!

[diamondstar1] 08/9/2020 21:25

I agree Bermuda. In fact, I feel that Amryt Senior Management have done a stellar job in boosting the companies revenue stream. But I do wish there was a bit more news - in between the big results eg Interim and Final. Example, potential in-licensing or out-licensing opportunities.

[bermudashorts] 08/9/2020 19:54

If AP101 results are positive then it shouldn't need a springboard - wouldn't it be the first treatment ever approved for EB? Then add in the prospect of the sale of the priority voucher.............

[bermudashorts] 08/9/2020 19:24

Papillon,

lol thanks for the clarification

[diamondstar1] 08/9/2020 19:16

I didn’t realise you had a dual profile Papillon, as ultrasharp.

I must confess - I was hoping to hear some positive news from Amryt, before the highly anticipated EASE Ph3 results in ?late Sept-Nov.

With the $60 million cash position, they could in-license another marketed product, or perhaps in-license another early development product. With AP-103 moving from pre-clinical to clinical possibly next year, my feeling is that another project would be beneficial, to take the focus off the AP101 (Episalvan) program.

[papillon] 08/9/2020 00:44

I guessed it was a public holiday for something in the USA today, Bermudashorts, when advfn continued to show Friday's chart action on the DOW. Let's hope that my modest top up of AMYT today proves to be prescient when the AMYT ADR's shoot up on optimistic speculation on Nasdaq tomorrow! Fingers crossed!

PS enjoy your posts on the lse AMYT bb.

ATB ultrasharp (I post as ultrasharp on my mobile because advfn wouldn't recognise the log in I use on my lap top. When I tried to use the papillon nickname on my mobile advfn informed me that the name was already in use! As if I didn't know!!)

[bermudashorts] 07/9/2020 18:50

ultrasharp

The markets are closed in the US today, it's a public holiday (Labor Day)

[bazworth] 07/9/2020 18:23

Given the recent volumes we will doubtless not notice the difference!

As long as we all keep smiling!

[ultrasharp] 07/9/2020 18:01

No trading on Nasdaq today.

[bazworth] 07/9/2020 14:42

Of course you have!!

[papillon] 07/9/2020 14:13

Just had another 500 shares top up. Paid £1.61 per share. Now got 6k shares. That was my final top up. FINGERS CROSSED I have done the right thing. Probably find out within the next month!

[charlie_munger1] 06/9/2020 17:48

Nicely explained papillon. It will be interesting to see what the share price does leading up to these results. Hopefully they don't keep dropping, instead they perk up a bit.

[papillon] 06/9/2020 17:03

Don't forget, charlie_munger that buying (or continuing to hold) AMYT at the moment is a gamble on the EASE phase 3 results. What the odds on success are we can only guess at the moment. I like to think it's better than 50/50, but who knows? No one!

Whatever the odds the upside will be much greater than the downside. Last years merger with Aegerion which gave AMYT a US$150m+ revenue stream, entailing the exchange of a chunk of Aegerion's debt for new AMYT shares, the placing leaving AMYT with US$60m of cash and the issue of the vouchers (that could be worth up to US$85m) to old AMYT shareholders already on the share register when the merger was completed (as compensation for losing their sole rights to AP101) has meant the downside to the AMYT share price could be very marginal if AP101 proves to be useless. However I don't believe that any upside is currently factored into the AMYT share price if AP101 proves successful (unlike with FARN over 2 years ago). In fact I think selling by nervous holders, allied with a lack of buyers, pending the outcome of the EASE phase 3 results is having a depressing effect on the AMYT share price

Whatever, I'm continuing to hold and might have another small top up. That wouldn't be the case if the merger with Aegerion hadn't taken place. If that merger hadn't occurred then an AP101 failure would have decimated the AMYT share price and the risk would have been too high for me to hold more than say a grand's worth! The converse is, the upside would have been much, much, greater on a successful outcome to the EASE trial.