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Excellent news. Looking at the Middle East only, Amryt now has distribution agreements in place in Lebanon, Jordan, Syria, Saudi Arabia, Kuwait, Qatar, Oman, UAE and Bahrain and we know that they are currently negotiating reimbursement in Turkey. Pretty impressive geographical coverage from a standing start less than 18 months ago when they signed the Lojuxta license. Looking forward to seeing how that translates to sales.

Michael Von Forstner appointed as Head of Risk Management and Pharmacoepidemiology. 'His skills will broaden Ergomed's premium service offering within PrimeVigilance, and build new revenue streams in pharmacoepidemiology and risk minimisation services, meeting high demand for these services.' https://investegate.co.uk/ergomed-plc--ergo-/rns/key-hire-in-pharmacoepidemiology-services/201805250700082474P/ http://www.terrapinn.com/conference/world-drug-safety-congress-europe/speaker-michaelvon-FORSTNER.stm

A successful SCIB1 combination trial makes a licensing deal for the whole platform, not just SCIB1 more likely. There are hundreds of combination trials ongoing so competition is tough and several successful treatments may well emerge. However, if the SCIB1 trial is the success we all hope and expect it to be, it will be of interest to all pharmas with a PD-1, not just Merck. Increasing response rate for Keytruda validates the concept that ImmunoBody can increase response rates in PD-1 checkpoint inhibitors and they all need some help!

Thanks for your posts - always good to look at the whole picture and you're certainly digging deep!.

For the sake of any newer holders who may be reading this board, when Inanaco suggested that physicians may prescribe SCIB1 off label as a monotherapy, I don't think he means that doctors will prescribe SCIB1 in place of chemo or checkpoint inhibitors in late stage patients with cancer in situ. I believe he means in the adjuvant setting (to prevent recurrence of cancer after surgery). Inanaco, perhaps you could confirm yes/no. It was a simple and genuine question a straightforward answer from you would have been appreciated (and much less effort for you).

I have no idea what you're talking about. What discussion? You have suggested that SCIB1 might be prescribed off label as a monotherapy. My question was why would any physician prescribe SCIB1 as a monotherapy? It isn't designed to operate as a late stage treatment, that's Moditope's territory and that's why I asked whether you meant in the adjuvant setting.

No problems, thanks anyway

But why would anyone prescribe it off label as a monotherapy? Or do you mean in the adjuvant setting?

I would be amazed if any pharma would sign a non-exclusive licensing deal for SCIB1.

.........at least a much larger trial, whether it's called a phase IIb or phase III is irrelevant. Unlikely to need both a IIb and a III though.

Balerno - yes

Sorry to labour the point but it's important to clarify. Are you absolutely certain he was talking about doubling sales and not response rates?

Ah right thanks. Would be good if Krafty could clarify exactly what CH said, whether it was that SCIB1 could double Keytruda response rates and Krafty then extrapolated that to produce potential sales figures or whether CH actually said SCIB1 would double Keytruda sales? When it comes to patient nos. for phase III trials, the benign safety profile of SCIB1 will also do no harm (excuse pun)

Where did you see/read/hear that report? If phase II trial is successful in combination with Keytruda then they'd need to go on and carry out a larger (probably randomised) trial before they could submit an NDA to the FDA, although randomisation with a drug using electroporation as a delivery method does present some challenges when it comes to trial design.

Thanks very much for the feedback Jimbob. Appears to have been handled well by the BOD - swift action taken to protect IP, a sensible settlement reached without an expensive and protracted court case and additional research handed over.

Interview with Nigel Newton http://www.proactiveinvestors.co.uk/companies/stocktube/9346/bloomsbury-publishing-in-a-very-strong-and-exciting-position--9346.html

May well be somehow linked but the placing shares haven't yet been admitted to AIM afaik.

Jimbob, Going back to the issues raised in your 13.28 post on Sunday. 1) Interim review for AP101 is scheduled for Q4 at which point it seems that Amryt will apply for FDA Breakthrough Therapy Designation and open US trial centres. Not so sure December was a slip of the tongue - we shall see!! 2) The comments re. marketing AP101 in other rare diseases based on existing PTW approval is intriguing. Although they already have European approval, the ultimate goal must surely be to also secure FDA approval for each market (disease) they intend to cover. We know they have been talking with the FDA and have completed the additional non-clinical studies requested. I assume that this evidence will also be used to support the small proof of concept studies in other diseases and that the next step will be to apply to both FDA and EMA for orphan drug designation. If and when that happens it will obviously be announced via RNS. 3) re. the Amicus data and the effect on the EASE study. The study size will only be increased by 28 patients and the primary endpoint stays the same but looks like they will exclude certain patients with milder form of the disease that can heal spontaneously and therefore risks distorting placebo response. Will be interesting to see precise changes when the Clinical Trials Register is update.

They have that - it's here https://www.youtube.com/watch?v=CXyPYib5JWc

Why not? His modus operandi is to invest at start-up/very early stage in private companies, take them to IPO and then move on to the next one. Nothing at all wrong with that, it provides much needed capital for these companies. He still holds 24m Amryt shares. As others have said, he stood down from the Board over a year ago and was only a non-exec director. Even if he were still on the Board, it's not at all unusual for non-execs to sit on the board and invest in several other bios at the same time. Open Orphan aren't in direct competition with AMYT - they're just operating in the same field of medicine. They will be marketing different drugs to different patients. If anything, it's reassuring that Friel's next project is another bio in the orphan drug field, it shows he sees value and potential there. Finally, none of this has any impact on the future success of Amryt. That depends entirely on how Lojuxta sales grow and how AP101/2/3 perform.