The latest Investing Matters Podcast episode featuring Jeremy Skillington, CEO of Poolbeg Pharma has just been released. Listen here.
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This is an interesting point. From the FDA's perspective, although Filsuvez was not as effective at the 90 day point there was significant efficacy demonstrated at the primary endpoints. Considering the fact that the safety profile was good and there is no other approved therapy, I find it hard to see how they won't approve based on the AMRYT push to have KOLs on EB involved from an early stage. If patient advocacy groups are saying we want this and it is safe, surely that is better than no treatment at all.Then again, what do I know, the FDA approved OxyContin for headaches.
If the P3 data was very convincing then Filsuvez would already be approved in the US and Europe. However, there seems to be a lot of ambiguity in the results. There is nothing else currently available currently for EB so the regulators have to make a decision - is the data good enough? I think of Filsuvez as a cure in search of a disease - it's got a good safety profile but is it effective for EB? The European regulators have taken the easy option - wait for the soft data/feedback from the various interested parties. It will be interesting to see what the FDA decide to do. My view is that it will get some form of approval as the risks are low - it all comes down to the regulators opinions on its efficaciousness.
All of us that converted will definitely feel depressed but would be surprised if anyone has sold .....it was hard enough getting them ! Find the news alerts hard to read compared to LSE RNS's but am I right in thinking that the last bits of news have been Funds taking stakes in Amryt , hopefully that's so and will come good. But at the moment looks like those that sold up prior to conversion .... were correct to do so :(
What thoughts, other than a ‘sinking’ depression watching the share price fall each & every day!! Having said that, I am confident of the longer term, hopefully we will see some update early next month + approval from the FDA!!
thoughts leading up to PDUFA?
Got mine too! They look better in $
Just as I posted that last message, they landed in my portfolio
Nothing yet in my iii portfolio.
They said they were chasing it.
Still nothing in my Interactive Investor account. Very poor been nearly a month.
That’s the same message that I received today!!
Cheers
This is the message I got fro ii
We are experiencing difficulties with the Third Party who are depositing the shares with our US Custodian, we are acting upon their amended requests as they are received but at the moment we are unable to advise of a time scale for when the Amryt ADRs will be allocated to accounts.
Hi Bazworth Hope you find them soon, funny though that ii won't let you hold them in an ISA but on Halifax we can ! Mind you without good news it don't matter where they are held ;)
Anyone else still waiting for iii to resolve the transfer?
I'm with iii too and they're not on yet. I checked before the deadline that everything was ok and they said they would be transferred. I sent them a message yesterday to find out where they are but not had a reply yet.
Hear, hear richpassi!!
They’re pretty while on the NASDAQ!!
https://www.nasdaq.com/market-activity/stocks/amyt/latest-real-time-trades?random=61e2c67f56d1f
They'll turn up, let's hope it's worth it when they do :)
I’m with iii & still no!!
I have still not received mine yet on iii!
Anybody else in the same boat?
Regards Bantam
Will do.
I’m with iii and still nothing. Please post when you have yours Threeskins!
Anybody here with Interactive Investor? Have you received the ADRs yet?
Mine now showing
Has anyone had their account credited with ADR’s as yet?
Cheers & thanks