Today was a shock. I speak as someone, who has personally lost a seven figure sum since the CHF and ARDS trial results came out , I share in all of your disappointment . My greatest sadness is the implied losses of those investors dear to me , who range from my significant other, to best friends, neighbours ,siblings and even one of my own children . Why did they all lose so much...because over a life of investing , I have won far more than I have lost....and people have a habit of tagging along for the ride. It is ironic that in a post i made on YAHOO before these negatives results came today, I was pointing to the risk of differing age groups affecting the outcome....little did I realise that both age and preceding biologic treatments may have affected the outcome... but in a different way to the way I originally envisaged . I suspect our therapy was not able to achieve the same level of superior efficacy relative to the control , in a much older patient group relative to that shown in a younger cohort who were treated earlier . But first let me start with a health warning. Until the data is analysed, no one can possibly understand what is really going on. The press release explicitly states that the interim analysis has not yet considered any of the secondary endpoints which have been used as the basis for an EUA by other companies. Piecing together some of the colour surrounding the news release , I have established the following :
1) To have “flown through” two interim analysis at 30%and 45% against such a demanding requirement to show at least a 43% improvement in mortality over best available therapy , shows that we MUST have demonstrated a good amount of efficacy with the first 135 patients.
So what has changed ? I am led to understand that patient demographics changed dramatically mid trial. Recent patients who were enrolled are now often 10-15 years older. Furthermore, these patients were likely to have been more refractory, having been treated with many other agents for longer than earlier patients in the trial had been. Relative to the control, our efficacy was much more limited compared to the early success in younger , healthier patients who had not received confounding treatments. Remember unlike several months ago, standard of care has improved dramatically . Patients are now put on ventilators as a last resort, often after receiving cocktails of various anti virals ,spending much longer on high flow oxygen devices and now benefiting from other upgrades to maximal care recently introduced. According to the Market Herald , “this dilution of the pure effects of Remestemcel-l has made any data gathering essentially invalid for the trials primary endpoint “
It is ironic that Remdesivir had an easy ride to EUA. It was originally suggested it could reduce hospitalisation by three days with no improvement in mortality for patients that would not even be sick enough to enrol on our trial. Mesoblast had to show a 43% improvement, even after all the other new treatments were used prior to intubation. The gap between the best available standard of care has obviously narrowed, over the ambitious targets set based on the strong efficacy shown at the time of the Mount Sinai compassionate use data. Silviu referred to this effect as a “evolving treatment paradigm”. It’s rather like playing a game of tennis which starts off as a singles match and then halfway through, the opposition has been allowed another player on court to play against you. Furthermore, physicians are far more reluctant to intubate before testing out a whole range of new biologics..so that the remaining unresponsive patients have far more extensive fibrosis than was expected when handed over to US and rapid recovery is almost irretrievable .
So is all lost ? Absolutely not...but the management will have to eat a little humble pie short term. This months phase 3 revelations have enlightened us more about the "sweet spot ' of our MOA. Post analysis of the full ARDS dataset, i believe we will discover a subset of patients best suited to our therapy. The tone of todays conference call suggested to me that Novartis are treating today as more business as usual...but the press release issued by Mesoblast, reminds us that there are "other" unspecified conditions before the partnership becomes irrevocable. In someways the CHF trial might have been proven to be very badly designed ..but amazingly it’s efficacy in Class II mortality was beyond my wildest dreams . Furthermore this was achieved in both ischemic and non ischemic patients. In my opinion the market capitalisation is now way below the real value of Revascor alone. Several global Pharmas have already thrown their proverbial hats into the ring...so a heart partnership should crystallise value in due course.
Next up,we roll the dice in CLBP. I hope for Silviu’s sake he knocks one out of the park ..but lets face it ...if he had to take the dog out for a walk today..he would probably get it run over by a steamroller on the pedestrian crossing. Stay inside Silviu.
Today has been very frustrating . It might appear to many posters that Remestemcel has failed as a treatment for Covid ARDS ...but it did nothing of the sort. It just failed to show a 43% improvement over all other therapies... which is something totally different . If Novartis push ahead in offering to finance 3D manufacturing research and a full blown Covid ARDS trial , it will be obvious that the crazy Australian market has got ahead of itself once again by writing off the Professor . Not a clever thing to do ....in my opinion .
Please do not rely on any facts or opinions expressed in the above post when making an investment decision. OP
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