Proposed Directors of Tirupati Graphite explain why they have requisitioned an GM. Watch the video here.
Things are looking very good for Brazilian soya and the license auction we are expecting in H2, courtesy of the Trump tariff wars. But we can’t escape the fact that we need decent trial data, due before end Q2, I.e. end June. Perhaps a bit of nerves creeping in and some investors de-risking today? Or perhaps, the bid was dropped to allow the broker to build a bit of inventory? We will find out soon-enough....
this has to be one of the most solid risk/reward names on AIM...the company listed in march 2014 at 123p a share...you can now pick it up, substantially de-risked, post several funding rounds and years closer to full-scale commercial development for 102p... I have a pet theory that a single UK institutional seller has taken us down here...perhaps people are waiting to see if it drops thru 100p and then breaks lower for the real bargain? in my experience, it just doesn't pay to get too cute about these things....in terms of valuation, i think the tannery technology justifies the share price here on its own. But we get a whole lot more, including the protective equipment servicing contracts in the US, which come with a decent and very stable top-line. buy.
I've got stockholm syndrome when it comes to Purp. I actually miss our tormentor when he/she isn't on this board. maybe he/she was just a cfd short-seller who wanted to cause maximum panic amongst the PI faithful and, having partially achieved his aim - assisted by some redemption selling by institutions, covered his CFD and moved on? we will probably never know.....I quite liked the thought that he/she was a genuine sociopath/psychopath, however. it was more fun in its way. the more I look at the investment that Lonza (what a chart!) has put into exosomes, the more convinced I am of the value to that part of the RENE business in time. I have no real clue on stroke, etc. It's a 50 bagger if it comes right so there's a lot of optionality to be had down here. Failure is the most likely option and that's what the market is pricing for both here and in stem cell plays in the US; it's not so dumb to place a small bet on the other side in such circumstances. there are strong fads and fashions in biotech and no small amount of luck....
the hyper-rational thing for Sarepta to do is to make a paper bid for SUMM's DMD assets.NOW..that way, they hedge themselves if the gene therapy route becomes problematic... given the move in the Sarepta stock, they could even take a view and go ahead of our 48 week data....Even if the 48 week data wasn't good-enough, the all-in paper price for SUMM ($500mn? 4I doubtx current mkt cap?) would now be a rounding error to Sarepta investors, obsessed with the gene-therapy prize and convinced their CEO can do no wrong....I doubt the institutional holders of SUMM would mind holding Sarepta paper.
Sarepta $SRPT has leaped out into the front of the race to develop a once-and-done gene therapy for Duchenne muscular dystrophy. With their R&D day in full swing Tuesday, company execs and the senior researcher on their groundbreaking human gene therapy study posted a first look at the promising results seen in three young patients who received treatments in a small study with no control which will involve a total of 12 boys. The data are very early, but the immediate response seen in the first few months has inspired the company to believe that it is on the right track to get a new therapy to these patients in as little as two years — provided all the stars align in its favor. “If you were me, looking under the microscope, you would be so amazed you wouldn’t sleep at night,” says Jerry Mendell, the noted gene therapy expert at Nationwide Children’s Hospital in Columbus, OH who is leading the project. CEO Doug Ingram called the results a “home run” during a preview of today’s presentation. Looking over the timeline, Ingram told me that it was conceivable that they would be ready to roll with a therapy in 24 months, but that would require a near perfect execution of the plan, with no nasty surprises. That doesn’t happen very often in biotech. But they’re trying. Hard. Baird’s Brian Skorney called it “amazing,” and the market agreed. The stock, which has been climbing north steadily over the past few months, rocketed up 56%. The main goal of this first human study is safety, but investigators also tracked how each of the first three boys in a cohort of six boys aged 4 to 7 responded based on some well understood biomarkers. And while the numbers represent only three patients, small numbers and initial results like this are key in gene therapy — with the caveat that there’s a ton of additional work that needs to be done to prove that the benefits are life-changing for the boys and durable for years to come. The first picture looks stellar, easily outstripping expectations. Here’s what Mendell has been losing sleep over, for good reasons: • Mean gene expression, as measured by percentage of micro-dystrophin positive fibers was 76.2% and the mean intensity of the fibers was 74.5% compared to normal control. Breaking that down on a patient-by-patient basis the percentages on micro-dystrophin expression in muscle fibers demonstrated some variability, ranging from a low of 59% to 83%, while the percentage of dystrophin-positive fibers fell in a more narrow band of 73.5% to 78%. • Biopsies run by investigators showed a mean level of micro-dystrophin of at least 36.5%, ranging up using a different measure. • Levels of creatine kinase in blood — an enzyme that leaks out of damaged muscles which is used to diagnose the disease — plunged by a mean of 87%
you make a fair point. but no-one should be in this stock for a few million quid here or there in Lojuxta. we're surely here for phase3 EB, etc. etc. just because the share price has drifted we have to make sure we don't lose sight of the price and don't get sucked into being overly bearish (which leads to selling at the wrong time)...
�We believe the microbiome represents a new paradigm in biomedicine, both for understanding drug response and as a novel therapeutic modality,� said James Sabry, Genentech�s SVP and global head of partnering. Genentech have just partnered with a UK microbiome player, Microbiotica. Microbiotica is really a meta-genomics platform, spun-out of the Sanger institute - i.e. a top-down genomic approach to finding biomarkers and other targets, rather than the more conventional, more clinical/commercial product focused 'bottom-up' approach utilised by 4D. Not directly relevant to 4D but i'd prefer to see deals in the microbiome space like this, especially involving respected mega players like Genentech, than not.
This is what happens if you get any positive data in NASH/ fibrosis..it�s such a key area of unmet need. The trial below was a phase 2.... From Fiercebiotech today: Using an old Roche drug, Madrigal Pharmaceuticals has seen its stock soar 130% on its latest fatty liver disease trials data.
Another phase3 COPD failure for AZN. I do wonder if AZN will be back to license with us again and that�s the long game we�ve been playing ... TERRANOVA trial did not meet the primary endpoint of a statistically-significant reduction of exacerbations in patients with chronic obstructive pulmonary disease
An interesting read.....see link. Of course, no mention of 4D or its trial launch. We are so far under the radar its ridiculous - too far?? It's not helping that there's a seller out there, so there's little opportunity to gain any share price traction until he's done...I think he's a redemption seller. He'll stop when people stop selling his UK fund - which won't be long. FTSE is starting to outperform globally. thank gawd for the likes of woodford. at least he backs things all the way. https://www.nature.com/articles/d41586-018-05208-8
Never been a ramper. Just not my style. But progress here is genuinely world-class/ground-breaking. The microbiome theme has been out of investor focus for a couple of years now but it�s back and it�s a far more mature technology now than it was in 2015. 4D is now a lot closer to large partnering deals and commercialisation milestones and yet the stock has been shunned. I think it�s going to squeeze. A lot.
very good! liked that....yea, you're probably right. I prefer to see it as 'masterly inactivity'.....I'm pretty sure there's a lot going on under the hood...just got to wait. as you wrote a while back, it's the sort of stock which suddenly gaps a lot higher on news (or lower)....see the spike at C4X a few weeks back....
See below. AZN�s respiratory pipeline not progressing as they would like....wonder if they regret ditching the licence agreement? Given our recent focus on COPD, is another licence deal in the offing? AstraZeneca provides update on GALATHEA Phase III trial for Fasenra in chronic obstructive pulmonary disease GALATHEA Phase III trial did not meet the primary endpoint of a statistically-significant reduction of exacerbations in patients with COPD
I don't get it either....It's not the first time US / UK biotech valuations have made no sense. If you were Serepta, why wouldn't you use your expensive paper to takeout Summit? At 5.8bn, you could afford to make an offer to the Summit board it simply could not turn down....
As predicted on this board....good news for us... Sarepta�s approval for eteplirsen�� or Exondys51�� in the US remains one of the most controversial OKs in FDA history, earning a rare label that says the biotech has yet to produce evidence the drug works. But lightning won�t strike twice on the regulatory pathway for this biotech. The biotech reported Thursday afternoon that the CHMP is prepping a negative vote, barring the drug from the continent. And Sarepta shares immediately tumbled 5% in after-market trading.
agreed..the other thing that the market overlooks is Barlow, the CEO. he's the real deal....no large pharma is going to partner with a discovery engine unless the credibility of the management is extremely high. it is here. the market just hasn't got around to discounting that yet....
It feels significant that we have a specialist biotech / pharma fund taking a chunk of stock off a capitulating generalist. The key point is that Healthinvest just don�t need to �go there�. They have all of global small cap pharma to play in so why invest in a company which is up for sale after a US cough and cold failure? The only reason they�ve turned up is because of significant risk reward. Hope so anyway! This has been a traumatic ride - deep value that really has plumbed the depths. Note, Healthinvest also invested in Summit Therapeutics last month. They�re smart....
we've just got to wait for Miton to finish selling. that's the only reason we are here, surely....(plus some year-end tax-loss stuff). as someone else wrote, it has to be nonsensical to be below the share price we were at last year when there was zero news on gib and when the capital position was a lot tighter than it is now. i did have a look at the most recent miton micro-cap portfolio update letter...it said that they'd moved away from stocks where there were delays in cash realisation.....i guess, despite all our excitement over gib, gib is a one-off and an institution like Miton might chose to look thru that. In core operational terms it's still is a story for tomorrow - particularly the membrane biz where the order momentum has got to build. the monitoring biz is a nice little self-contained business that is already washing its face (just).
A blow - excuse the pun - to an erectile dysfunction peer/ competitor product....it�s too expensive to hit FDA requirements...rights to be sold. FDA Confirms Vitaros Regulatory Pathway �Company Seeking Partner to Develop Vitaros in U.S. Company Evaluating Strategic Alternatives SAN DIEGO, April 16, 2018 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today announced the outcome of its end-of-review meeting with the U.S. Food and Drug Administration (FDA) on the New Drug Application (NDA) for Vitaros(TM)�(alprostadil, DDAIP.HCl), a topical cream for the treatment of erectile dysfunction.� The preliminary end-of-review meeting minutes support a plan to address issues cited by the FDA in its February 15, 2018 Complete Response Letter (CRL) for the Vitaros NDA.� Specifically, the FDA confirmed during the meeting that the company should develop a new Vitaros formulation that reduces the concentration of DDAIP.HCl from 2.5% to 0.5% in order to address the tumor promotion and partner transference safety concerns noted in the CRL.� The FDA also confirmed that two new Phase 3 clinical efficacy trials with the reformulated product should be conducted prior to resubmitting the NDA and that the trials should include an assessment of the potential risk of enhanced sexually transmitted infections with the new formulation. In addition, the FDA requested certain pharmacokinetic assessments that we expect can be completed as part of the requested Phase 3 program and any additional clinical or commercial safety data generated prior to a resubmission. �Lastly, the FDA stated that the Chemistry, Manufacturing and Control (CMC) section in the resubmission will need to be updated with data generated during development of the new formulation. The FDA previously issued a CRL for the Vitaros NDA, indicating that it could not approve the NDA for Vitaros in its present form, identifying deficiencies related to CMC and whether the modest treatment effect of Vitaros outweighed certain safety concerns specific to the 2.5% concentration of DDAIP.HCl contained in the current formulation.� "While we are pleased that the FDA has outlined a clear regulatory pathway for Vitaros, which we believe provides a path to approval in the U.S., the cost and timeline associated with a reformulation effort and completing additional phase 3 clinical trials exceeds our current resources and our ability to raise additional capital.� Therefore, we have initiated discussions with interested parties for the U.S. Vitaros rights to enable its continued development and potential approval in exchange for financial terms commensurate with a development stage asset.� In parallel, the Board of Directors has determined that Apricus should evaluate strategic alternatives or othe
It takes a long time for global consumer groups to take the plunge and change formulae/ingredients. I guess if it's not actually broken, why take a risk in trying to fix it? But the environmental and performance pressure is really building now. They know they've got to get on with it and prove sustainability. It is just a matter of time and patience, as you say, chilting. I think the exciting thing that people have overlooked is that once you're supplying this stuff, you are guaranteed to be doing so for many, many years because the same conservatism that made adoption slow makes replacement or use of another supplier very unlikely.