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ORPH is looking cheap - maybe a good fit for AMYT?
Nothing really happening here - just view this slight pullback in context. It jumped to €7 far too quickly on sustained Blackrock buying. Now it's falling back a bit. The European banks index EXX1 is down about 2.5% today - BIRG is not even tracking this drop. BIRG has very sound fundamentals and is currently just trading at about fundamental valuation. Day to day price changes are irrelevant unless you're day trading the stock - two years down the road the current price will look cheap.
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.
I believe that the states ongoing reduction in its shareholding is directly contributing to the increase in share price. Many institutional buyers would have been hesitant taking positions while the state had significant control over the banks decisions.
As the states position decreases more investors will start to buy into an independent bank not controlled by the whims of politicians. There has been some criticism in the media of the price ranges at which the state has sold tranches but if they had not started reducing their holdings then this would probably have put a brake on the potential upside for BIRG.
BIRG was tracking the euro bank stocks (EXX1) reasonably closely until December. It probably should have outperformed that index last year given the various BIRG specific developments (Davy, Irish economy etc) The question is whether the 15% + positive divergence in performance over the last couple of months is valid. The trade volumes would suggest that this is primarily institutional trading so I tend to believe the stock is just re-rating to a reasonable valuation of approx €7 per share. it's probably close to fair value at present and any significant increases from here would need share buybacks, dividend clarity or exceptional results.
I think it's all down to the details in the P3 trial results - there seems to be a lot of ambiguity in the data so it's probably hard for the regulators to make a clear cut decision
Probably worth confirming that with ii. My broker needed confirmation to convert to ADS, otherwise they would have taken no action which would have left me holding untradeable AIM shares
One thing that is hard to understand is why the FDA left it so late to declare that the additional data is a major amendment of the NDA. It's not like they just got this data recently. I figure that they are probably being very cautious with this review. A lot of the trial data points are marginal so they need to be absolutely certain about statistical significance before approval.
Bermuda - I agree that it is most likely positive and could be for broader labelling. Not great news for the CVRs but not negative news either.
The delay is "to allow time to review additional analyses of data previously submitted by Amryt" as this additional data submitted is considered to be a major amendment of the NDA. So, the question is what does this additional data show - positive or negative? Amryt could provide an update on the specific additional data that is being reviewed.
Interesting timing for this announcement, within a few days of the PDUFA. Maybe they just want to ensure that the AIM delisting decision is out there now so that it won't be connected with whatever the FDA decides.
Thanks Bermuda. I just wonder if they could have done it some other way e.g. a share issue to the existing shareholders at that time. I know this would have caused dilution but I think that the potential cash payout of up to $85M is not the best use of capital - however, as I am going to (hopefully) benefit from it I'm not complaining!
I still cannot understand the logic of why AMYT decided to issue the various CVRs. Growth companies generally re-invest any profits or surplus funds in the business instead of paying out valuable cash in the form of dividends, which is essentially what the CVRs are. It just seems like a very inefficient way of utilizing cash in a fast growing business
The conference call was very positive and although they could not give any specific replies to questions about the PDUFA it appears that things are proceeding as expected.
Same pattern as the last few days on nasdaq yesterday with large trades towards the end of the session, however these were mostly sells.
Still selling down a bit today, however the individual trades are all small retail volumes. Will be interesting to see if there are any larger institutional buys later in the session as happened on Friday