Member Info for Bermudashorts

'The U.S. trustee on Thursday objected to the sales plan of bankrupt Aegerion Pharmaceuticals Inc, saying the drugmaker is rushing the all-stock deal worth more than $400 million with Britain’s Amryt Pharma PLC and risks missing out on better offers. '

https://www.reuters.com/article/bankruptcy-aegerion/us-trustee-raises-concerns-about-aegerions-planned-sale-in-ch-11-idUSL2N23S1MF

All done and dusted, will be interesting to see any TR1's now

https://www.investegate.co.uk/angle-plc/agl/result-of-placing/201906251719094017D/?fe=1&utm_source=FE%20Investegate%20Alerts&utm_medium=Email&utm_content=Announcement%20Alert%20Mail&utm_campaign=Angle%20PLC%20Alert

We have no evidence whatsoever of any comments made by AN regarding funding.

Researcher, you made claims on SCLP regarding emails from the BOD but your post has been deleted (presumably by admin.) I seem to remember way back making other claims regarding a friend of yours at a conference. Unless you're prepared to back up these posts with hard evidence then perhaps it's best not to say anything.

Very sensible to raise now and to raise a decent amount. Interesting that £8.6m will be coming from US investors and also worth noting that the RNS contained an update on cash position at year end (April 2019) - a healthy £11m.

''The Company proposes to raise approximately £8.6 million (before expenses) through the issue and allotment, conditional on Admission, of the US Placing Shares at the Issue Price through Beech Hill Securities. '

''the Company generated revenues and grant income of £0.9 million, an increase of 25 per cent. on the previous year. The gross margin on revenues is expected to be in excess of 75 per cent. The Company's loss for the year ended 30 April 2019 following planned expenditure on research and development and clinical studies is expected to be approximately £9.0 million (in line with expectations) with year-end cash at £11.0 million up nearly 47 per cent from 30 April 2018 (£7.5 million).'

sushifishman -

Yes thanks. I read your post on ADVFN and replied there

Well that explains one of them - Chairman, Miroslav Reljanovic is responsible for 200k buy. So over last couple of weeks we have significant purchases from the CFO and now a £600,000 buy from the Chairman.

https://www.investegate.co.uk/ergomed-plc/ergo/director-pdmr-shareholding/201906250700142659D/?fe=1&utm_source=FE%20Investegate%20Alerts&utm_medium=Email&utm_content=Announcement%20Alert%20Mail&utm_campaign=Ergomed%20plc%20Alert

Yep, just under £1.5m in total

A couple of links below that may be of interest to Sareum holders.

https://endpts.com/in-surprise-switch-bristol-myers-is-selling-off-its-blockbuster-otezla-promising-to-complete-celgene-acquisition-just-later/

https://twitter.com/JebKeiper/status/1143131323864952833

yep, good call Christatrdg

'Summit Therapeutics plc (NASDAQ: SMMT, AIM: SUMM), a leader in new mechanism antibiotic innovation, today announces that the Biomedical Advanced Research and Development Authority (‘BARDA’) has increased the total value of its award for the clinical and regulatory development of Summit’s precision antibiotic ridinilazole for the treatment of C. difficile infection (‘CDI’) to up to $63.7 million.'

http://www.globenewswire.com/news-release/2019/06/18/1870133/0/en/Increased-BARDA-Award-and-Option-Exercise.html

Interesting to note in light of AN's comments re. the use of Parsortix in clinical trials, that a new research paper has been published today by University Medical Center Hamburg-Eppendorf, Germany. The paper investigates the use of Parsortix for the analysis of PD-L1 expression on CTC's.

For any who may not be aware, immunotherapy and specifically checkpoint inhibitors have transformed cancer treatment over recent years. PD-L1 is a protein expressed on the surface of tumour cells and signals to PD-1 on the surface of a T cell telling it not to attack. In effect, it's a mechanism that allows the tumour to hide from the immune system. PD-1 checkpoint inhibitors such as Keytruda (Merck) and Opdivo (BMS) block the pathway and unmask the tumour thereby allowing the immune system to attack. These drugs now have multi billion $ annual sales.

The problem is that only around 30% of patients respond to checkpoint inhibitors in lung cancer and it's thought that responses increase with PD-L1 expression. Clearly with lung cancer, it's impossible to continually monitor PD-L1 expression via tissue biopsy and so it's easy to see how CTCs may be of interest in clinical trials.

You can download the full paper from this link:-

https://www.mdpi.com/2072-6694/11/6/835

Another big purchase from CFO, Richard Barfield. This time just under £173k bringing the total buys from him announced this week to over £250k.

These are the scientific advisors and consultants employed by Motif when carrying out due diligence and trial design for Iclaprim. You can make your own minds up whether you believe they knew what they were doing or whether anonymous posters on a stock bulletin board know better.

Scientific Advisory Board

Jay Tischfield, M.Phil, Ph.D, FFACMG, – MacMillan Distinguished Professor of Genetics, Pediatrics and Psychiatry. Executive Director, Human Genetics Institute of New Jersey.

G. Ralph Corey, M.D. – Professor of Medicine and Infectious Diseases, Duke University Medical Center, Durham, North Carolina, USA;

Brad Spellberg M.D. – Chief Medical Officer, LAC and USC Medical Center, Professor of Clinical Medicine, Keck School of Medicine at the University of Southern California, Los Angeles, California, USA;

Mark Wilcox, B Med Sci, BM, BS, MD, FRCPath. – Consultant, Head and Professor of Medical Microbiology, Leeds Teaching Hospitals and University of Leeds, UK; Lead on C. difficile, Public Health England, UK.

Scientific Consultants

Medicinal Chemistry
Timothy A. Blizzard, Ph.D., Medicinal Chemistry Consultant
Matthew J. Wyvratt, Ph.D., Drug Discovery Consultant
Jerauld S. Skotnicki, Ph.D., Medicinal Chemistry Consultant
Mark L. Greenlee, Ph.D., Medicinal Chemistry Consultant

Pharmacology
Euan MacIntyre, Ph.D., Pharmacology Consultant

Toxicology
James S. MacDonald, Ph.D., Toxicology Consultant

Clinical
John M. Amatruda, M.D., Clinical Consultant

Regulatory
Robert J. McCormack, Ph.D., Regulatory Consultant

Drug Development
Sergio Lociuro, Ph.D., Development Consultant
Catherine Strader Ph.D., Drug Development Consultant

Below are measures taken when designing REVIVE 1 & 2 re. liver tox.

1) Changed from weight based to a fixed dose
2) Reduced that fixed dose from 80mg to 40mg for patients with liver impairment
3) Carried out liver function tests at screening, and 4 other time points during study - remember average length of treatment was only 7 days
4) Patients with elevated LFTs at TOC required to return for additional tests until results returned to normal

There's more, but you get my drift. Genuine question, given your criticism of the BOD and trial protocol, tell us what else you think they should have done, what errors/omissions have they made in the trial protocol?

Positive RNS to start the week and a vote of confidence from the CFO with a share purchase of just under £87,000.

https://www.investegate.co.uk/ergomed-plc--ergo-/rns/pdmr-dealing/201906100700066005B/

When asked during the webcast yesterday, GL confirmed that it's highly likely the FDA will require a trial with a comparator arm (as opposed to single arm Iclaprim only trial) , so yes, it will be blinded.

The point I was really trying to make was that some of the criticism being thrown at the BOD in terms of the running of the trial is unfair IMO. The trial protocol specified that patients with raised LFT's should be followed up and once the protocol is agreed and the trial underway then it really is completely out of Motif's hands. They wouldn't have known until the trial had been completed and unblinded whether any patients at all had raised AST/ALT levels and whether they were Vanc or Iclaprim patients.

Vascular,

You are overlooking the fact that this was a blinded trial - Motif would not have been aware of any of these results until the end of the trial, after the data had been unblinded and analysed. The patients could have been recruited and dosed at any time in the previous 2 years and any follow-up (even if they could trace them) would have been useless. Also once the database has been locked you can't add to it.

Best hope for MTFB now perhaps is that the FDA allow them to carry out the extra trial in a different setting ie. HABP. This was the next step for Iclaprim in any case and a successful trial would allow them to submit for approval for both ABSSSI and HABP at the end of the trial. Motif had already been working on HABP trial anyway and seem to recall that design was complete and it was ready to go. Big question is funding of course.

The Clinical Trials Register has been updated to show the addition of a further 5 study centres in the US - California, Florida (2), Pennsylvania and South Carolina. This doubles the no. of centres in the US to 10 and brings the worldwide total up to 52 different locations.

Can you summarise what facts lead you to believe that the FDA have lied because that's quite an accusation.