Saturday, 8 March 2014

Teacher's recipes: Lentil dhal the thermomix way

Teacher's recipes: Lentil dhal the thermomix way: Same recipe as below, adapted by me for Thermione.  Again, in memory of Steve Neville. Lentil Dhal: two shallots, peeled and halved gin...

Monday, 11 November 2013

Accommodation in Port Douglas - Port Douglas Coral Apartments Review

Tuesday, 10 September 2013

Mesoblast - The recent MSB landscape needs reinforcement.
Mesoblast - The recent MSB landscape needs reinforcement.
Mesoblast Research Written by Al Mcleish, MSB has traded in the range of ~ $5-25 to ~ $7.50 this calendar year. Last trade ~ $5.55 . The recent MSB landscape needs reinforcement to prospective investors and those contemplating additional investment in this stock and the imminent unfolding of events should disclose a strategy of astuteness and foresight. It has been a remarkable year of progress and you need to understand that from what is provided below. In contemplating what lies before us in terms of news flow, I can only reiterate that MSB looks cheap. The markets that MSB products will address are ‘ blockbuster ’ in status, largely unmet and focus on indications that are common in occurrence and have exponential growth . If I combine the annual expenditure on the top ten ‘indications’ of which MSB are progressing, it tallies north of $ 100 billion. I say ‘unmet’ because numerous drugs have failed, get shelved, have side effects or are proven inefficient. Many such failures have chemical derivation whereas Mesoblast’s MPCs are humanly derived from adult donors and the safety and efficacy are therefore not under question. I say ‘common’ because many indications stem from age related ailments such as heart, arthritis, back pain, hereditary diseases or self- induced illness, originating from, for example, carrying excessive weight. Obesity for example, is of epidemic scale…and off the cuff induced indications are blood diseases, diabetes, heart ailments, joint problem- arthritis, respiratory matters, and cancers…a non- exhaustive list. MSB are at the apex in adult stem cell global development scrutinising a diverse set of most commonly occurring aliments to which they will hopefully apply their product with unsurpassed therapeutic benefit. About 6+ months of background exposes an already remarkable year, 2013. On the Phases (Jan.) Very promising Phase 2 lumber spinal fusion results which will prompt the commencement of a Phase 3 trial. (Jan.) FDA approves Phase 2 Rheumatoid Arthritis trial . (see commentary below) (April) - The interim analysis of a Phase 2 trial of allogeneic, or “off-the-shelf”, Mesenchymal Precursor Cells (MPCs) injected into damaged intervertebral discs completes a six-month follow-up for all 100 patients enrolled. The data is very positive. (Feb ) Strategy reiterated for inflammation and immunity indications and MSB initiated new preclinical studies in inflammatory lung diseases, (asthma and pulmonary fibrosis). These enclaves of invigorated development by MSB should be most appealing to Teva as they are existing, prioritized channels but are also indications that big pharmas are actively searching for novel therapies. (Feb) MSB announced that they were in the midst of a Phase 2 clinical trial in 60 patients with early type 2 diabetes not adequately maintained on oral glucose-reducing agents. The patients were being evaluated over 12 weeks for effectiveness of a single intravenous MPC dose on changes in various inflammatory markers, including C-reactive protein (levels rise when there is inflammation), and on blood glucose control. (This trial has completed enrolment and results should be released in Q4 2013). MSB are to initiate a Phase 2 trial in the second half of FY 2013 to evaluate whether a single intravenous MPC injection can stabilize or reverse endstage kidney disease in diabetics. Teva reiterated their commitment to a Phase 3 for CHF. It commencement is imminent. One guesses that both Teva and MSB will announce this soon, noting that it would seem of greater significance initially to MSB but be more material to Teva as it progresses. Undoubtedly this trial will cement the long-term relationship and increase the potential to collaborate on other indications. On broader development and risk mitigation. (Feb) FDA agrees that Mesoblast's manufacturing process in Singapore is acceptable for Phase 3 clinical supplies. Mesoblast plans to use product manufactured in the Singapore plant in global Phase 3 trials. (Feb) Three new patents regarding composition of matter were granted in the US, extending exclusive rights out to 2029; Importantly exclusive rights granted in China to 2025 on composition of matter where MPC are derived from any source. This latter point ought not be underestimated for the simple reason that China is becoming less of a ‘mimicker’ and more of an owner. (March) The mere fact that MSB held a highly successful placement back in March for $170m at a price of $6-30, to global strategic investors reflects solid support in the developments, strategy and vision. A war chest of ~$317m of cash not only prompts big pharma to clear their throats, but also reflects in MSB’s ability to fund their own phase 3s if deemed appropriate. This was an astute corporate action. (April) CEO (Silviu Itescu) receives the inaugural “Key Innovation award 2013” from the Pontifical Council for Culture at the Vatican's Adult Stem Cell Conference. The other awardee was Sir John Gurdon, Nobel medicine laureate. (June) E xclusive commercial rights were gained in Japan through to September 2025 to all compositions-of-matter and uses of its Mesenchymal Precursor Cell (MPC) technology platform, irrespective of the MPC tissue source . This is significant in light of the fact that legislation is likely to go before the DIET in September to fast track stem cell commercialization. The draft outline effectively enabled companies that could show safety and a degree of efficacy from Phase 2 trials, on relatively modest trial numbers, to begin commercialisation while continuing Phase 3 testing or they may not have to commit to a phase 3. This would bring Japan into line with South Korea and would bring about commercial therapies 2-3 years ahead of schedule. (Such proactive development is largely attributable to Shinya Yamanaka picking up one of last year’s Nobel Prize for Medicine with Sir John Gurdon for their iPS research (specifically reprogramming mature cells to become pluripotent) and the Japanese Government has committed a US$1bn to R&D over the next decade). There are certain issues that need to be clarified, for example, whether a phase ll trial needs to be undertaken on Japanese subjects, but, these will be resolved in due course. . . Just think about what America may be contemplating? ,… it will get them involved in Japanese partnerships and possibly incite them to alter their own FDA constitution. Be mindful that MSB own a web of IP over MPC cell composition and derivation, so there will not be many companies who have the ability to bypass MSB in this space. ===================================================================== What proposals could be put forward which might explain the recent MSB share price lethargy ? For much of the fiscal year of 2013, unfounded negativity (promoted by a certain broker) prompted short selling. This concern has dissipated and the broker has gone back into hibernation presumably for the simple reason that his negative calls are being proven incorrect. Ignore the ASIC website short positions. I have been monitoring these. There are 3 dilemmas. (1) ASX turnover is a complete mismatch to the ASIC data. (2) the ASIC data has disclaimers everywhere about data inaccuracy and (3) there is a disclaimer by ASIC that short positions may not be reported . Teva…Why the delay in commencing Phase lll CHF trials.? There is no specific reason. Teva are committed. Teva are funding the trial. What I could suggest, is that as time passes, the other indications on which MSB progress in collaboration with Teva including neurologic disorders such as stroke and Parkinson's disease become more valuable. Additionally, other indications in which there is no partnership, should become more attractive to other possible partners. And do I hear you say that there have been a lull in recent announcements… ? Well read on. So let’s comment on anticipated near term news flow. Teva communicated firstly, throu