Member Info for djframboise

No idea why this is not showing on LSE but more good news this morning.

AMRYT PHARMA PLC
Released 07:00:00 23 December 2020
Amryt Granted Orphan Drug Designation by the FDA for AP103

DUBLIN, Ireland, and Boston MA, December 23, 2020, Amryt (Nasdaq: AMYT, AIM: AMYT), a global, commercial-stage biopharmaceutical company dedicated to developing and commercializing novel therapeutics to treat patients suffering from serious and life-threatening rare diseases, is pleased to announce today that the U.S. Food and Drug Administration (“FDA”) has granted orphan drug designation for AP103 for the treatment of Dystrophic Epidermolysis Bullosa ("DEB"). AP103 is based on Amryt's gene-therapy platform technology and offers a potential treatment for patients with DEB, a subset of EB.
The FDA’s Office of Orphan Products Development (“OOPD”) grants orphan drug designation to support the development of medicines for rare diseases, that affect fewer than 200,000 people in the United States. Orphan drug designation may allow Amryt to be eligible for a seven-year period of U.S. Marketing exclusivity upon approval of AP103 and a waiver of the Prescription Drug User Fee Act (“PDUFA”) filing fees, subject to certain conditions.

AP103 is based on a new gene therapy delivery platform, in-licensed by Amryt in March 2018, that utilises a non-viral delivery vector, HPAE (Highly Branched Poly ß-Amino Ester), designed to deliver the correct collagen VII gene into skin cells.

Joe Wiley, CEO of Amryt Pharma, commented: "Receiving an orphan drug designation from the FDA for our gene-therapy candidate, AP103, is a significant development for patients suffering from EB and provides additional momentum to our development pipeline. Unlike other gene therapies that rely on viral vectors, AP103 is based on a novel polymer-based topical delivery platform, which we believe offers potential advantages in the gene-therapy field and has potential to be used in other genetic skin conditions.”

Massive UT (uncrossing) trade. Not completely clear on how that all works. Still think we're well on the road to recovery but will need the confirmation of that to push the SP on and up. I remain confident here.

A bit like a dodgy toilet - the smells keep coming and need a good flush. This one has gone round the u bend....

Pfizer are manufacturing the vaccine in a smallish town Puurs, between Brussels and Antwerp. It's better known for the Duvel brewery! iI used to pass it every day on my way to one of my bigger outsourced warehousehouse projects. I have a friend working there and he reckons it's a pretty manic period but that's hardly surprising. It's also a very international setup.

FILTER and move on.

If it was on Facebook then it must be true!

More good news. Interesting that they chose to do a norning RNS this time iso mid-morning like last time. Will we get another spike and fall or a morelasting rise? Who knows - this is AIM of course. I had much given up on this before December's news but have been adding small ammounts since. Might be an interesting day. GLA. DJF

Thanks for the summary Dubliner. Great work. DJF

tecbadger, did my first visit to West Vleteren on Thursday which is one of the worlds top-rated and hardest to get hold of beers. Have a case of 24 West Vleteren12. It is nectar!

Stu, he's a big unit these days. I think he still does punditry work although not on the channels I get.

"Europe pi s s ing about waiting for 26 Members to tick boxes for vaccine to be rolled out, while The old little uk are well ahead."
And where was the vaccine made ? Little old Belgium of course.

MIKODX, Eurofins is a global setup with sites everywhere. I actually have one within 400m of my house in Belgium. Plenty UK based also. Still think we should be able to sell as much as we make.

Armatrader, spent 10 years working in IT on European customs and export. It's a minefield but manageable for bigger companies as we can get everything system driven due to economies of scale. For the smaller companies, extra manual resources may well be needed. That is an additional cost. We ship into Russia and sometimes have to wait days for clearance and heaven forbid if there are issues with the paperwork. The reality and enormity of this starts to become clearer.

Target is to filter to$$ers like you. Target achieved.

First message and it's s***! Thanks but no thanks.

Hate crime? Don't be daft. The comments were OTT but he didn't call anyone a nazi.

Alas_Smith, how many times has the clap-trap about the Millenium bug been rolled out. Their are parallels of course in that resources were totally tied up on that instead of projects that would take the businesses forward. I personally spent a year of my life earning big bucks to make my company systems safe over the change of the millenium. It was boring but necessary work and the fact that their was such limited impact was down to so many like me doing the work we did. I'd rather have been doing something more creative but that with the overtime helped me put down the money for the deposit on my current house. Now as an IT Customs Specialist, I'm going to get to make the big bucks again because of this Brexit BS. Our systems are not ready as we started far too late and hoping that some sort of deal will be cobbled together. It's going to be messy otherwise.

Strap yourselves in - the rollercoaster is off again! This ride is never dull. GLA and good weekend. DJF

Bizarre trades today, 13,20 and 120. What's that all about?

Real rollercoaster of a couple of weeks. Have added a few more today and lowered my average again. What the last spike showed was just how quickly good news can cause a massive move on a low volume share. GLA