@Sojourner Your observation is reasonable when applied to the majority of reported clinical trials undertaken which fail to reach their primary endpoint ...especially when dealing with instances (which are all too common with biotech companies ) of cherry picking data from subsets of patients . The requirement for rigorous well controlled randomised controlled studies are universally accepted as the required benchmark for approval ...but there are exceptions... for exceptional treatments. The FDA is supposed to ensure that clinical trial results are not twisted to provide “false positives”....but the FDA has constantly cocked up in allowing underpowered trials of 300 patients which often lead to inconclusive findings because they are inappropriately powered. In the case of Mesoblast’s Covid ARDS results, I am sure Novartis will be waiting to see if the biomarker data from the trial supports the level of efficacy shown for mortality at 60 days when used concomitantly with dexamethasone.
I also laugh when people moan about using a 60 day not a 30 day endpoint and say there should be a multiplicity adjustment. Personally if i was choosing a therapy I would be more interested in 60 day survival rather than 30 day!
Using your logic, I assume that you also think it is a “scam” that only an open label Recovery trial, conducted in the UK was the principal reason that dexamethasone has become the biggest breakthrough in the treatment of intubated Covid 19 patients in the UNITED STATES. In fact the Recovery trial was also responsible for undermining all the negativity around the potential use of Tocilizumab (Actemra Roche) in combination with Dexamethasone. If your not prepared to take my word for it ...why not read the latest published article in the Lancet dated May 1st.
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00712-1/fulltext
“In summary, the RECOVERY trial provides the most definitive evidence thus far to address the controversy over whether tocilizumab should be added to our armamentarium of treatments for severely ill patients with COVID-19. The answer is yes. Questions remain about tocilizumab's efficacy and safety in other settings, such as those with C-reactive protein concentrations of less than 75 mg/L and among paediatric patients (the RECOVERY group is doing a separate trial in children, which is ongoing), and among more gender and racially diverse populations. Importantly, the 28-day mortality rate of 31% in the tocilizumab group, although lower than the placebo group, remains unacceptably high, and thus additional therapies are urgently needed to further reduce mortality in severely ill patients with COVID-19 “
Now consider this . The combination of Tocilizumab and Dexamethasone appears to be the future gold standard treatment for ventilated patients with Covid Ards ...until along comes little old Mesoblast and blows them out of the water in the under 65 year old treatment category. It may require another confirmatory trial but i am pretty confident that an Emergency Use approval will be coming our way in due course.
I also expect the inflammatory biomarker dataset to confirm that Remestemcel for Covid ARDS will also be highly efficacious against Influenza A induced ARDS.
If I am right...i don’t think Novartis will be wanting a divorce anytime soon ! Unless you can propose another therapy with a 14% mortality rate for ventilated severe Covid 19 patients ?
Thought not .
Please do not rely on the facts or opinions represented in this post when making an investment decision. OP
(20min delay)