Charles Jillings, CEO of Utilico, energized by strong economic momentum across Latin America. Watch the video here.
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Technically it is a recommendation. The Approval is granted later by the EU Commission it is a few days/weeks later. I think that will count for the CVR
Does that count as approval for the CVRs or does the approval in 67 days count.....a couple of days before the linear scale reaches the big fat zero on the 1st July?
I have emailed the EMA via their online query form and they responded to say that a decision is yet to be reached on the AMYT application, they said to monitor EMA CHMP minutes and agendas so maybe we wait till next month.
yeh said by end of March, hopefully won't follow FDA though...
Aren't we supposed to hear if the CHMP recommendation this monthm after the expert panel announcement? The.monthly CHMP meeting was this week.
Sold back Mondays Coinbase Global Inc buy at $161 for $181@ 8.30pm .
12.5% in two day .
Sold them back Wednesday 9th, 7.30pm $7.05 went to 7.53pm by 8.30pm . ( Fridays manic deal made 9% in 5 work days , the higher $7.5 would of been 15% )
AMYT ...dropped to $6.19 my order did not lift . ( 5.5% from Fridays buy $ 6.17 )
Bought more of the Friday buys as below.
All placed around 4pm .
PayPal Holdings $ 95......... ( -5% ) Lifted 7.43pm
Coinbase Global Inc $ 161 ( -2.3% ) Lifted 7.52pm
Boeing $ 170..................... ( - 5.5% ) Lifted 8.50pm
The last of 9 ( not 7 as below ) USA buys I decided to start placing at 6.15pm lifted Nasdaq $6.53 this the final of the 20 orders
AMYT $6.53
NIO Inc $ 18.60
ROBINHOOD MARKETS INC - A $ 10.86
Coinbase Global Inc $ 165.00
PayPal Holdings Inc $ 100.00
Boeing $ 180.00
Prothena Corporation PLC $ 31.00
3D Systems Corp $ 14.78
GSX Techedu Inc $ 1.44 from the bottom order they lifted .
The last of 7 USA buy I decided to start placing at 6.15pm lifted Nasdaq $6.53 the final of the 20 orders
The others
NIO Inc $ 18.60
ROBINHOOD MARKETS INC - A $ 10.86
Coinbase Global Inc $ 165.00
PayPal Holdings Inc $ 100.00
Boeing $ 180.00
Prothena Corporation PLC $ 31.00
3D Systems Corp $ 14.78
GSX Techedu Inc $ 1.44 from the bottom order they lifted .
Given the P3 results it was pretty much a coin toss whether the FDA would approve or reject.
The slow decay of the share price in recent weeks was in hindsight a good indicator of what the smart money was doing.
As I posted previously this was a case of a cure looking for a disease and the data just didn't stack up sufficiently
The weird thing is that the underlying business would appear to be growing quite well. Wonder whether we will drift further then be snapped up??!!
FFS Why did we convert ? Congratulations to those that binned it.
Bizarre!!
ORPH is looking cheap - maybe a good fit for AMYT?
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.