Amryt Pharma Share Discussion Threads

[punter6] 26/4/2022 12:40

Are we expecting good things from the Q4 results next Wednesday?!

[onceaday] 22/4/2022 16:49

If you are interested in the format of the post-CRL meeting then here are the guidance notes..

› mediaPDF
Post-Complete Response Letter Meetings Between FDA and ANDA Applicants ...

[bermudashorts] 22/4/2022 16:10

......but not in children and not specifically for EB.

[chica1] 22/4/2022 16:04

Well it's good we get something for the CVR's.I thought they'd end up being completely worthless.

I still don't understand the rns completely though because Episalvan was already approved for partial thickness wounds by the EMA in 2016.

[alphabravo321] 22/4/2022 15:51

From the RNS...The FDA communicated that it had completed its review of the application and has determined that the application cannot be approved in its present form. The FDA has asked Amryt to submit additional confirmatory evidence of effectiveness for Oleogel-S10 in EB. Amryt intends to discuss with the FDA the nature of the data required to address the Agency's concerns.

[onceaday] 22/4/2022 15:45

Its unlikely that Amryt will be allowed to present any new data at the review meeting. I have listenned to enough CEO's with CRLs to know that Amryt will likely get a 1 hour meeting during which time the FDA will explain the deficiencies that precluded approval. Amryt will need to then arrange further meetings to discuss the requirements for a resubmission. That is likely to take 9 months even if the extension trial data is acceptable.

[chica1] 22/4/2022 15:44

Sorry I missed that CVR's will be paid

CHMP adopts positive opinion for Filsuvez® for the treatment of Dystrophic and Junctional EB

Positive opinion based on largest ever pivotal global Phase 3 EASE study undertaken in EB

Filsuvez® would be the first and only approved treatment in Europe for EB Patients

DUBLIN, Ireland, and Boston MA, April 22, 2022, Amryt (Nasdaq: AMYT), a global, commercial-stage biopharmaceutical company focussed on acquiring, developing and commercializing novel treatments for rare diseases, is pleased to announce that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the approval of Filsuvez® in the European Union (EU) for the treatment of partial thickness wounds associated with dystrophic and junctional Epidermolysis Bullosa (EB) in patients 6 months and older. EB is a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approved treatment.

Based on this CHMP recommendation a decision by the European Commission (EC) is expected on the Filsuvez® application within 67 days. The centralised marketing authorisation would be valid in all EU Member States as well as in Iceland, Liechtenstein, and Norway. The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK is expected to grant authorisation within the same time period.

The CHMP positive opinion is supported by Phase 3 data from the EASE trial which was the largest ever global trial conducted in patients with EB, performed across 58 sites in 28 countries.

As a result of the CHMP positive opinion, the EMA Contingent Value Right (CVR) issued to Amryt shareholders and option holders prior to the acquisition of Aegerion will now become payable. The quantum of the EMA CVR payable will be determined by the terms of the CVR Deed Poll and CVR holders will be notified in due course of their entitlement

[alphabravo321] 22/4/2022 15:41

My estimate is 3 sevenths or so of original value

[onceaday] 22/4/2022 15:39

The PR states that the EMEA CVR is now payable but the value is not disclosed so we have to wait. The value was calculated on a sliding scale - max being approval in Dec 21 and zero by July 22, as I recall.

[iamnotanumber6] 22/4/2022 15:38

As a result of the CHMP positive opinion, the EMA Contingent Value Right (CVR) issued to Amryt shareholders and option holders prior to the acquisition of Aegerion will now become payable. The quantum of the EMA CVR payable will be determined by the terms of the CVR Deed Poll and CVR holders will be notified in due course of their entitlement.

[chica1] 22/4/2022 15:36

Interesting the news today but wasn't Episalvan approved for partial thickness wounds by the EMA in 2015

DUBLIN, Ireland, and Boston MA, April 22, 2022, Amryt (Nasdaq: AMYT), a global, commercial-stage biopharmaceutical company focussed on acquiring, developing and commercializing novel treatments for rare diseases, is pleased to announce that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the approval of Filsuvez® in the European Union (EU) for the treatment of partial thickness wounds associated with dystrophic and junctional Epidermolysis Bullosa (EB) in patients 6 months and older. EB is a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approved treatment.

[dlm2602] 22/4/2022 15:34

Presumably this approval trigger the 20p per share CVA payout for EMA approval? If so when?

[alphabravo321] 22/4/2022 15:33

FDA review meeting in May, I think the new positive dara from the 12 month EASE assessment might turn a few heads in FDA land

[richpassi] 22/4/2022 15:26

I blooming hope so Alpha ;) mind you it is Amryt .....on Nasdaq :(

[alphabravo321] 22/4/2022 15:04

I assume the market will react with the RNS

[alphabravo321] 22/4/2022 14:58

Back of the facking net

[bermudashorts] 22/4/2022 14:56

Details here:-

'The full indication is:

Treatment of partial thickness wounds associated with dystrophic and junctional epidermolysis bullosa (EB) in patients 6 months and older.'

[bermudashorts] 22/4/2022 14:52

Here it is:-

'The CHMP gave a positive opinion for Filsuvez* (birch bark extract) for the treatment of epidermolysis bullosa.'

[richpassi] 22/4/2022 14:48

Freewheeling on Stocktwits has just written about EMA positive opinion, trying to find confirmation but no luck yet ....anyone looking ?

[alphabravo321] 27/3/2022 20:08

https://tickeron.com/ticker/AMYT/?utm_source=stocktwits_free&utm_medium=news&utm_campaign=TICKER_SUMMARY&utm_term=Stock_127913_AMYT&utm_content=9065972

[onceaday] 27/3/2022 16:13

..or.maybe just a glass of tap water 😄