Shield Therapeutics Share Discussion Threads

[ny boy] 03/4/2019 08:22

Usual mugging, it’s been happening on a regular basis since the 30p’s, each decade the same!

Dips will be bought as usual

[ny boy] 03/4/2019 07:56

Agreed Nobby, FDA approval at the end of July would be a game changer, commercial deals and potential up front payments out of China could also be significant, plenty of goodies coming up.

[nobbygnome] 03/4/2019 07:14

The most important part of the results to me is the talk about further commercial deals around the world. Unlike most biotech companies there is no spectre of any fundraising as the money will come flooding in as deals are signed and sales increase. I am taking the US approval as read.

The bottom line is the company is in an excellent position to grow and is clearly undervalued. Of course in the casino that is AIM, that doesn't mean the price will go up today after the strong rise recently....but it surely will in the not too distant future IMHO!

GLA

[someuwin] 03/4/2019 07:13

Commenting on the preliminary results, Carl Sterritt, CEO of Shield Therapeutics plc, said: "2018 was a year of transition and Shield is now well positioned to deliver further positive news through 2019. I expect Norgine to continue to develop the sales performance of Feraccru(R) in the UK and Germany, and we anticipate concluding further out-licence agreements to cover additional geographies. In the US I look forward to the 27 July 2019 PDUFA date, which has the potential to unlock the world's largest prescription pharmaceutical market to Feraccru(R), which has continued to demonstrate its effectiveness over the last 12 months in two demanding clinical trials. In the meantime, we will continue to build upon these positive data, which have demonstrated Feraccru(R)'s non-inferiority to the leading IV iron therapy, its effectiveness in treating IDA in CKD patients, and the application of Feraccru(R) to patients with iron deficiency."

[someuwin] 02/4/2019 20:53

Cheers. Tomorrow should be interesting...

"The company will present more detailed analyses of the data, including the secondary endpoints and safety parameters, at its upcoming preliminary results"

Results tomorrow 3rd April

Analyst briefing tomorrow

Investor briefing Monday 8th April

[nobbygnome] 02/4/2019 20:42

Well it is really all about b. because they won't make any money until a licensing partner is appointed, although clearly a makes b much more likely😜.

But that doesn't really answer your question. All I know is that it will be much higher than the price now....

[someuwin] 02/4/2019 20:25

Thanks for that valuable insight Nobby.

So, the question is, what share price level after:

a. FDA approval?

b. Announcement of licensing partner?

[nobbygnome] 02/4/2019 17:31

Just realised I haven't revealed the subject of my discussions with the CEO after the Proactive presentation.

Ferracru clearly is already approved in Europe and so one would expect the FDA to approve it. Nevertheless, there have been some notable differences between the EMEA and the FDA on drug approvals in the last few years; tofacitinib is one example which comes to mind. But in my experience these examples are nearly always down to differences in interpretation of safety data not efficacy. The CEO confirmed to me that they have already made a couple of PSUR (routine safety updates from patients once a drug is on the market) submissions to the EMEA and these showed no issues of any concern from a safety point of view. He also confirmed this extra data has been submitted to the FDA....

The other major question I asked him was about the licensing partner in the US. He said that they would wait until the approval (hopefully in July) and then very quickly sign up the partner who offers the best deal. He implied they are already lined up and it is just a case of the final bids once the approval is known. That is also very encouraging to me.

In answer to another PI about ongoing questions from the FDA, he said there have been a number of questions but they have answered all of them in the requisite time and there was nothing substantive in any of those questions. More encouraging information.

In summary this is not a Motif Bio or Immupharma situation, Ferracru is proven to work, has lots of safety data and has a sound manufacturing process as proven by the EMEA approval and ongoing in market activity. Those are the three issues which regulators are worried about.....So IMHO it is a no brainer that approval will follow in July shortly followed by the signing of a licensing partner!

[nobbygnome] 02/4/2019 16:24

Certainly looks like I timed my buys well! Might have to get a few more for the road. After all the market cap is still not back to the level before the announcement about the apparent trial failure which never was. Complete madness....but nothing surprises me on Aim any more...

[juuunx2] 02/4/2019 15:01

Just arrived into this one

[red army] 02/4/2019 14:53

Added today,

[ny boy] 02/4/2019 14:16

Nice 50k buy @ 77p, certainly some big buying today ahead if tomorrow’s results.

[ny boy] 02/4/2019 13:42

Not more getting mugged, just hold and relax as we head towards 100p +. Obviously dyor as usual

[ny boy] 02/4/2019 11:18

Just thinking of all those that got right royally mugged on the pull backs in the 40’s,50’s & 60’s DOH!

Only other stock I have added (MSYS), everytime it drops back to 1p, I have a few more, dyor as usual

[ny boy] 02/4/2019 10:48

No fixed price stock available to buy at present

[ny boy] 02/4/2019 10:39

Sounds like a few in the City have heard some news they like?

Shield Therapeutics plc, will be announcing its final results for the financial year ended 31 December 2018 on Wednesday 3 April 2019.
Analyst briefing
A briefing for analysts will take place at 9.30am on Wednesday 3 April 2019 at the offices of Walbrook PR, 4 Lombard Street, London, EC3V 9HD. If you would like to register, please contact Walbrook PR on 020 7933 8780 or email [e-mail]
Investor briefing
A briefing for investors will take place on Monday 8 April 2019 at Copper Bar, Balls Brothers, 6 Adams Court, Old Broad Street, London, EC2N 1DX from 4.30pm for a 4.45pm start and will be followed by refreshments. If you would like to register, please contact Walbrook PR on 020 7933 8780 or email [e-mail]

[stoneme] 02/4/2019 10:32

Off she goes again ?

[ny boy] 02/4/2019 09:04

Probably because there is little free stock, breakout coming!

[someuwin] 02/4/2019 08:54

Cheers Nobby - good to see you here.

...Can't buy many online now.

[ny boy] 01/4/2019 17:52

Well done Nobby!

Another one in the “no-brainer camp” should start motoring as we get closer to the summer 90/110p before end of July FDA decision, then skies the limit! 🤞

[nobbygnome] 01/4/2019 15:39

I saw Shield present for the second time at Proactive a couple of weeks ago. I traded the shares after the first presentation and made money on the spike. However, after the second presentation and as a result of questioning the CEO one to one, I am increasingly convinced Ferracru will be approved by the FDA and that they will appoint a licensee soon afterwards.

I was waiting to post as I built a position but the bird is flying and I probably have enough now. I will post more later but in summary this is close to a no brainer for me now!

Nobby

[ny boy] 01/4/2019 15:13

Breakout should be a big one this time, sit back and enjoy the ride here imo, many getting mugged on each small sell off too.

[ny boy] 01/4/2019 12:20

Strategic advisor appointment, market likes, what’s not to like about these, tick tock to FDA news

[someuwin] 01/4/2019 12:03

Breaking out a lot higher very soon