Member Info for liquid1

Another place to look is at PDUFA dates, and in doing so there is perhaps reason for cheer. During January and February there were 15 PDUFA dates, 3 of which resulted in Complete Response Letters and 12 of which were approvals, some of which not only occurred early, but very early. At least three of these were approved in December 2017, two months before the PDUFA date. Of the approvals during the first two months, 9 of them were NDAs and 6 were sNDAs.

http://eyeonfda.com/2018/03/pdufa-dates-adcomms-and-approvals-2018-so-far/

At the moment, just over 9% of hospitalised ABSSSI patients treated with vancomycin suffer from vancomycin-associated acute kidney injury, which extends hospital length-of-stay by five days.

Generally, those patients require a specialist nephrology physician consultation and acute dialysis, which can be costly.

More than just ABSSSI?

One key issue with almost all antibiotics is that some bacteria have become resistant to their effects, rendering them useless.

Motif has previously presented data showing that iclaprim still works on a variety of antibiotic-resistant pathogens such as methicillin-resistant (MRSA) and methicillin-susceptible (MSSA) Staphylococcus aureus.

The Cystic Fibrosis Foundation is also funding important in vitro (outside of the body) testing to help develop iclaprim as a treatment for cystic fibrosis patients suffering from lung infections.

MTFB’s Mcap is 131m AMP own 9.53% So 9.5% is about 12.5m even before FDA approval next Wednesday!

https://scr.zacks.com/News/Press-Releases/Press-Release-Details/2018/MTFB-Completes-Submission-of-NDA-for-Iclaprim-article/default.aspx

There are an estimated 3.6 million people hospitalized with ABSSSI every year. We conservatively estimate that 20% of patients have renal insufficiency, based on published data (Halilovic et al., 2012). We believe iclaprim could attain peak market share among these patients of 20%. We model for a full course of treatment costing $3000 and an inflation rate of 2%, which leads to peak sales of approximately $500 million in the U.S. Outside the U.S., we believe Motif will sign a commercialization agreement that will result in an average 15% royalty on net sales, which we estimate will peak at approximately $225 million. Using a 90% probability of approval and a 15% discount rate leads to a net present value for iclaprim in ABSSSI of $475 million. After factoring in the company’s cash position, potential cash from the exercise of outstanding warrants, and dividing by the fully diluted ADS share count of 18.6 million leads to a valuation of $28 per share. The stock continues to trade at a significant discount to our valuation, thus offering investors plenty of upside at the current price.

Shares outstanding 209.98m Free float 109.90m https://markets.ft.com/data/equities/tearsheet/summary?s=AMP:LSE

What will the Mcap be next Wednesday on FDA approval? 5m or 10m??

· PDUFA action date set for February 13, 2019



Motif Bio plc (AIM/NASDAQ: MTFB), a clinical-stage biopharmaceutical company specialising in developing novel antibiotics, today announced that the U.S. Food & Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for iclaprim, a targeted, Gram-positive investigational antibiotic, for the treatment of acute bacterial skin and skin structure infections (ABSSSI). This means that the FDA has determined that the application is sufficiently complete to perform a substantive review. The NDA has been granted Priority Review, and the FDA has set a target decision date under the Prescription Drug User Fee Act (PDUFA) of February 13, 2019.

Pooled data from phase III trials confirms Motif Bio’s iclaprim drug is safer than gold standard Share 08:09 11 Jun 2018 Pooled data from the REVIVE-1 and REVIVE-2 trials confirmed that iclaprim is non-inferior to vancomycin and significantly safer bacteria Motif Bio is in the process of gaining approvals in the US and Europe for iclaprim New data for Motif Bio Plc’s (LON:MTFB) has confirmed that its next generation antibiotic iclaprim was better tolerated and safer than a rival drug in two recent late-stage studies. Over the past six months or so, Motif has published top-line data from the phase III REVIVE-1 and REVIVE-2 trials, which showed iclaprim was safe and well-tolerated in patients with acute bacterial skin and skin structure infections (ABSSSI). READ: Motif closing in on approvals, potentially looking for partners Having had some extra time analyse the pooled data from the two studies, the AIM-quoted firm has repeated that iclaprim is just as good as (the technical term is ‘non-inferior to’) the current gold standard medication, vancomycin. Motif also confirmed that iclaprim was safer than vancomycin, with no deaths reported among the iclaprim-treated patients compared to three in the vancomycin group. The company also repeated that its drug was found not to negatively affect patients’ kidney function, a key issue for some people taking rival treatments. None of the patients taking iclaprim showed signs of kidney toxicity, compared to seven patients in the vancomycin arm. “Iclaprim has a fixed dose, with no dosage adjustment required in patients with renal impairment or in obese patients, and no kidney toxicity was observed in the REVIVE trials,” said Gary Hock, principal investigator in the REVIVE-2 trial. “Iclaprim, if approved, may offer advantages over standard of care antibiotics in hospitalised ABSSSI patients, particularly those with renal impairment and/or diabetes.” Save hospitals time and money Motif Bio believes iclaprim can save hospitals, and patients, money by reducing the amount of after-care required for patients who develop kidney complications as a result of taking vancomycin. At the moment, just over 9% of hospitalised ABSSSI patients treated with vancomycin suffer from vancomycin-associated acute kidney injury, which extends hospital length-of-stay by five days. Generally, those patients require a specialist nephrology physician consultation and acute dialysis, which can be costly. No resistance One key issue with almost all antibiotics is that some bacteria have become resistant to their effects, rendering them useless. Motif has previously presented data showing that iclaprim still works on variety of antibiotic-resistant pathogens such as methicillin-resistant (MRSA) and methicillin-susceptible (MSSA) Staphylococcus aureus.

That’s a shame!

Outlook for 2019

· Expect to deliver progress on underlying EBIT and lower separately disclosed items, leading to substantial progress on reported operating profit

· Reported operating profit will be a primary focus going forward, together with free cash generation

Thomas Cook (India) Ltd Declares Strong Q3 FY19 Results Press Trust of India | MUMBAI | Last Updated at February 05 2019 13:20 IST https://wap.business-standard.com/article/pti-stories/thomas-cook-india-ltd-declares-strong-q3-fy19-results-119020500536_1.html

Let’s hope it’s positive! Too much negativity with Brexit rubbish!

The Company has now delivered sufficient tonnage to the potential off-taker for them to undertake a full kiln smelting test and expects to receive the outcome of the test in the next three weeks following which the Company anticipates that a long term off-take agreement with the off-take partner will be reached.

Agree 3 weeks is on RNS By Friday there should be an RNS

Look forward to that. 3 weeks up Friday. The bulk sampling operation, combined with the increase in the vanadium price during 2018, has enhanced the profile of the Project. As a result, the Company has received numerous enquiries from potential development partners, a number of whom have carried out extensive due diligence. The Company continues to evaluate all enquiries and will update shareholders with further developments as appropriate. Peter Cox, CEO of Ironveld, said: "Our sampling programme is progressing to plan and we are confident of reaching a long term off-take agreement with our potential off-take partner, which would generate significant revenue for Ironveld. I look forward to updating the market further in due course."

50 days to drill, that's early April

Can wait till end of March when market will know which way sp is going!

News could land anytime next week!

Even Monday!

"Our sampling programme is progressing to plan, and we are confident of reaching a long term off-take agreement with our potential off-take partner, which would generate significant revenue for Ironveld," said Chief executive Peter Cox.

At the end of September, Ironveld began supplying 10,000 tons of ore to an undisclosed company, which is a unit of an international steel group.

Ironveld said Friday it has now delivered sufficient tonnage to the potential off-taker for the potential client to undertake a full kiln smelting test and expects to receive the outcome of the test in the next three weeks.

Upon completion, Ironveld anticipates that a long term agreement with the off-take partner will be reached.

"Our sampling programme is progressing to plan, and we are confident of reaching a long term off-take agreement with our potential off-take partner, which would generate significant revenue for Ironveld," said Chief executive Peter Cox.

Buys ! Nice

Sale of Team Internet

The Company received two offers for the acquisition of Team Internet

--The Company’s and Team Internet's managements that it will be possible to sell Team
Internet for substantially higher amounts than those offered today. Company’s management
recommends completing the proposed plan and only thereafter pursuing an active sale.

-- In the second half of 2019, the Company will act to appoint an investor banker to enable an
orderly sale process of Team Internet

--The bondholders will be granted a right to appoint on observer in connection with this process

http://investors.matomy.com/~/media/Files/M/Matomy-IR-Media/presentations/matomy-bhp-path-100119.pdf