Amryt Pharma Share Discussion Threads

[brummy_git] 28/1/2022 12:55

Likewise, I suspect most investors were half-expecting this to happen. Only 2 months to wait though.

Plus including the views of patients who have successfully used the treatment in trials could really help the FDA/EMA decision making processes - when it comes to labelling & application areas.

[alphabravo321] 28/1/2022 12:35

I had a feeling the EMA wouldNot decide before the FDA, seems like an obvious delay tactic, plus the inclusion of the voice of patients cannot be a bad thing

[richpassi] 28/1/2022 12:21

Well I gave it a go ....and what did we get more kicking the can down the road ;(

[richpassi] 27/1/2022 20:23

In Our Dreams !!! ;)

[whatno] 27/1/2022 18:22

Fingers crossed! If we are really lucky we could get a "double pop" from positive CHMP opinion then EMA/FDA approval.

[onceaday] 26/1/2022 18:56

Got an answer from IG, they are still "working on it"!

[richpassi] 26/1/2022 17:57

An insight from those across the pond can be followed on Stocktwits .....not the same as ADVFN or LSE but its another room to check into ;) Simply search Stocktwits then obviously search for Amryt.

[richpassi] 26/1/2022 16:57

Don't knock it They don't seem to smile for long across the water ;)

[cwa1] 26/1/2022 16:48

But...only...just :-)

[alphabravo321] 26/1/2022 16:45

It.is.alive

[richpassi] 25/1/2022 19:07

Been checking to see if my ADRs had been placed in my Trading Account that were held in my ISA ....each time it was a No .......Looked further .....they are in my ISA ;)

[gnnmartin] 25/1/2022 17:44

Bermudashorts, thanks. I did look there but did not spot that I could request a news feed. I'll look again, fortified by you advice.

[whatno] 25/1/2022 16:04

Has anyone heard anything from IG with regard to the delivery of the ADRs. I have not had a response to several emails sent to the UK helpdesk.

[whatno] 25/1/2022 16:02

I am guessing we'll know one way or the other before market open.

Fingers crossed for a positive opinion. A withdrawal will be difficult to spin as not being just as disastrous as a negative. Worth remembering the EMA previously approved the drug for partial-thickness wounds.

[bermudashorts] 25/1/2022 15:49

whatno -

Thanks for that. I was trying to find out a) when exactly the decision is made (ie. is it put to the vote during the same meeting or scheduled for another meeting) and b) when the decision has been made, when is it communicated.

Seems that the vote takes place during the same CHMP meeting and the info. in your 7011 means that one way or another we'll find out by Friday which way the decision went.

[whatno] 25/1/2022 15:45

Applicants also have the option to withdraw - I guess this is possible if it's clear during the meeting that they have failed to make a case.

If an applicant withdraws its application for initial marketing authorisation, a withdrawal Q&A is published in the CHMP meeting highlights on the Friday following the upcoming CHMP plenary meeting (see Table 1). For applications withdrawn during a CHMP meeting, the Q&A is published on the Friday following the next CHMP meeting.

I do wonder what time of day the documents are published? Given that Amryt normally sends out notifications around mid-day in the UK (pre-market in the US), I suppose it's possible that it could appear on the EMA site earlier.

[bermudashorts] 25/1/2022 15:40

gnmartin

It's possible to register with Amryt to receive updates. You can register on the Investors section of their website and select the type of alert's you'd like to receive. I've not registered myself so have no idea how reliable the service is but may be worth a try.

[whatno] 25/1/2022 15:37

If the CHMP gives a negative opinion on a marketing authorization application, a refusal questions and answers (Q&A) document is published in the CHMP meeting highlights on the Friday following the CHMP plenary meeting (see Table 1). This Q&A document can also be found using the Medicines search page. It provides basic information in lay language about the medicine and the reasons why it was not recommended for approval. Its target audience is the general public.

[gnnmartin] 25/1/2022 15:12

I have relied on the London Stock Exchange and on ADVFN for a feed of news relating to Amryt. Anyone know how I get a news feed now Amryt have given up the London listing?

[bermudashorts] 25/1/2022 15:10

alpha,

Yes, have tried to find out the process and timescales following an oral presentation (if it was required) and this is from the EMA:-

'The Committee, working party or scientific advisory group as appropriate shall not make any conclusions during these presentations in the presence of the company representatives or the third parties.

5. In all cases the applicant/marketing authorisation holder is informed of the trend at CHMP level at the end of the scientific discussion ahead of any formal vote to conclude the evaluation process.'

So whilst Amryt won't have a firm decision, they may well be aware by close of play of the likely outcome.

[cwa1] 25/1/2022 14:39

Thanks for that bazworth

[bazworth] 25/1/2022 14:33

iii have confirmed that they have done all that they need to do and are simply awaiting receipt. They are chasing though!! Just relieved that I haven't wanted or, worse still, needed to sell....!!

[cwa1] 25/1/2022 14:30

Ah, ask for me too please ;-)

[bazworth] 25/1/2022 14:26

I'm on the phone to them at the moment!!

[cwa1] 25/1/2022 14:23

Still nothing in from ii for me at least