There will come a time when everyone will be able to put this pandemic into some sort of otherperspective (shameless plug) . It is important to understand that the median age of someone who dies from Covid 19 is well into the 70’s. Then there is the other affected subsection of the population, those with comorbidities, who combined with the elderly, account for 96% of mortality . It seems less distressing to discuss in terms of statistics ....but that represents millions of mothers and fathers , grandparents , young kids, diabetics, those with cardiovascular disease, liver or respiratory diseases, etc. The link below is a brilliant evidential summary of the societal challenge we face today from the Coronavirus... but questions whether much is paranoia induced. I recommend that everyone views, because Covid 19 is killing off a percentage of the population that is highly vulnerable but arguably would “pass” not soon afterwards from a normal bad influenza season anyway.
VIDEO Whenever we have a pandemic , health authorities react by mass testing programmes, which cause a “casedemic” , which the webcast demonstrates by reference to testing programmes which followed H1N1. However, with respect to Covid-19/ARDS, I believe we are dealing with a whole different animal. It is one of the first asymptomatic viruses and is effectively as disease of the lining of the blood vessels....the statistics he provides will not reconcile with the delayed mortalities...evidenced by blood clots rising tenfold for those in there twenties ! I believe the commentator misses totally the long term damage caused by multi organ failure and fibrosis which are referenced in excellent posts by
@stanjupiter and others. I hope when the hysteria dies down, we will remember that Mesoblast is an essential part of stopping a zombie population emerging from the effects of this virus... over 50% of surviving ventilator cases may need “ assisted care” (not to mention the follow on hospitalisations) long after they get discharged. We know from multi organ failure resulting from graft versus host disease that Remestemcel-L (“Ryoncil”) can not only counter the cytokine storm, but help alleviate many of its longer term fibrotic complications. This is also evidenced by the long term review of mesenchymal cells in treating COPD and other peer review studies.
There is an interesting article in this Saturday’s Daily Telegraph in the UK, which is behind a paywall so i am unable to print verbatim. Summarising, Sir John Bell, one of the worlds top immunologists and Regius Professor of Medicine at Oxford University, said that vaccines would be too late to stop the second wave of infections coming in the Northern Hemisphere flu season....but he pointed out that lateral flow testing (which shows communicable viral load as opposed to antibodies) will, combined with mass testing, allow society to return to normal. Home test kits based on a saliva test are emerging which will give 99.5% accuracy and results in 20 seconds. One has the capability to see ten molecules of the virus in a single saliva sample compared with around 500 required for a conventional PCR test for the same result. Want to visit a loved one ? No problem...just take the test. Planning on a business meeting ? No problem, take the test. The test works by using microscopic holographic imaging from a digital camera which can detect the tell tale proteins of the virus.
“We can find someone before they are infectious,” said Greg Compton, chief executive of iAbra, the Bedfordshire company which has created the test.“
Then there is HALO, a British biotech company which has designed an app which can give you saliva based test which are up to 10 times more accurate than PCR.
So help is coming. Keep calm and carry on. When you approach the key flu season in your country, probably best to self isolate if you are vulnerable, but otherwise live life. Don’t skip you cancer screenings and remember that surveys show that up to 40% of the population are now suffering from ~Covid 19 related lockdown depression ...including 10% with suicidal thoughts...similar to the troll induced rates on this thread. Be kind everyone and take your vitamin B1 , C and D3 after consultation with your doctor of course.
So where does that leave Mesoblast ? It is obvious that there is some crossover in mortalities with influenza A. The emergence of a vaccine will only partially allay the mortality rate of the immune compromised or the elderly. Sir John Bell is adamant that vaccines will not be able to contain the impact of coronavirus long term. Not only will it mutate , but he points out that there is no silver bullet:
”For people with ageing immune immune systems, it will be difficult to get the same response as a 35 year old”
I salute the fine work of
@kervio and others in trying to model a Bayesian analysis to determine the likelihood of overwhelming efficacy in our forthcoming interim analyses. I will state categorically, that i believe we have a decent chance of an early stop at 45% if we can maintain a 40% differential in mortality with the placebo group. I would deem our treatment a relative failure if we have not stopped at 180 patients or 60% of the enrolled. I follow the science and note how the trial is being powered. I really cannot see anything other than an successful outcome....but I welcome contributions which can show otherwise. The key question will be what quantum of effect will our treatment provide? A very successful result will leave other competitors floundering. How will they hope to recruit for their clinical trials or compete. Our treatment will be expensive to manufacture so we need to show superlative performance . I heard Silviu state at a recent telephone conference that ARDS was 20 times the market of sr aGVHD . Long after the pandemic is subdued Mesoblast should be making billions form other forms of ARDS. It is noteworthy that sepsis represent 1 in 10 visits to the ICU in the US.
Result Dependent.
For those seasoned Mesoblast shareholders and shorters, you can be forgiven for thinking it is business as usual . Timelines from Mesoblast come and go with the seasons after all. You can be forgiven for coming to that conclusion but I suspect everyone is missing the point. It is essential that Ryoncil is the first across the finishing line. Assuming approval , insurance companies will be asked to approve a therapy based around pricing 25m cells per vial for an orphan disease, with the expectation of $320,000 price for a total treatment course for sr aGVHD. This pricing per cell dose might be compromised by moral outcry over the cost of mass usage of mesenchymal cells for a pandemic. Basically we will lose the right to recoup twenty years of equity risk and hard work...not to mention the opportunity presented by an exhaustive list of other orphan inflammatory conditions. I expect to see biological refractory severe Crohn's emerge as a wonderful opportunity for our cells...not to mention HIE which is one of the primary causes of cerebral palsy...which is effectively treating the effects of stroke in newborns. I could write pages on the conditions which will likely benefit from our treatment and form the basis of numerous label extensions to come. Was it really a surprise , that Amy Lightner at the Cleveland Clinic should be commencing a phase 1/2 study now into Ulcerative Colitis having worked with our mesenchymal cells for so many years in patients with Crohn’s ? The opportunities are endless. The last thing I expect the Board to do now is to be strong armed into discounting the price per vial, just as we get our first FDA approval.
Watch this space. We are now becoming results dependent. In my opinion , any successful trial phase 3 results, or possibly confirmation of FDA approval for Ryoncil, may trigger global partnership deals with industry majors. This will prove the catalyst for widespread institutional investment. Let’s face it ...very few fund managers have the time or confidence to sort the wheat from the chaf in biotechs. Only 1 in 5000 biotechs make it big and those are not good odds. They look for industry validation before jumping in at massively higher prices. If the share price was over AUS $100 in 24 months time it would not surprise me...but it might surprise others .
Please be careful with current market conditions ...when prices drop in a crash...shares sometimes have temporary periods of no liquidity and prices fall to crazy levels. Don’t be the person getting stopped out. I read that 43% of retail investors use some form of leverage when they invest so I find it sometimes reassuring to keep a proportion of my portfolio in cash. Just remember the great shares bounce back ! Also remember that the FDA can do unexpected things. It is not beyond the realms of possibility that a physical site inspection or a quality assurance issue, temporarily holds up authorisation (however unlikely after the ODAC vote)..particularly with quarantining affecting free movement of people. Following the ODAC committee meeting i felt like i had been reborn...I never thought the FDA would be so unprofessional in presenting their briefing pack but Mesoblast were so incredibly professional in stating their case that the day was won. It was a great reminder that none of our opinions really matter...just those of the FDA. I congratulate Mr Hoffman’s unbiased chairing of the meeting, which allowed the Committee to arrive at the right conclusion by following the science . Obviously, a successful RCT for Covid 19/ADRS will put the FDA right back in their box. I believe we are in the throws of a new era of regenerative medicine. Get with the programme or get out of the way !
Please do not rely on the accuracy of the facts or opinions expressed in the above post when making an investment decision. Biotechs are high risk investments and the risks should be carefully considered before investing . OP
(20min delay)