I have been away from HC for a while but been following the news. 1. The CHF results: From Dr. Emerson Perin "The trial results show that rexlemestrocel-L significantly reduces cardiovascular mortality when used early in heart failure patients at risk of disease progression, and provides durable protection from heart attacks or strokes in these vulnerable patients. New therapies have not materially reduced the high death rates from cardiovascular disease which is why these data have the potential to change the treatment paradigm for patients with advanced chronic heart failure"
Key words and these words that are worth BILLIONS, in my opinion - "when used early in heart failure patients". When. Used. Early.
So Mesoblast's Revascor should be given early. Not after other treatments have failed. We are talking about something like a VACCINE for CHF patients. So Prevention. Go ahead, challenge me on that conclusion I just made. "There was a 60% reduction in incidence of heart attacks or strokes and 60% reduction in death from cardiac causes when treated at an earlier stage in the progressive disease process." Again, pay attention to the "earlier stage treatment". So I am looking at REVASCOR as a drug or may be even as a vaccine. Not necessarily as a therapy as we thought all along. Also, in case you missed it, there was a reduction in heart attacks or strokes. Say what? Strokes? Strokes? We are talking the BRAIN as well? Not just the HEART?
Just a few hours ago, the FDA gave a CRL to Novartis for inclisiran, for unresolved facility inspection-related conditions. Novartis is a giant with know-how to deal with this and get inclisiran approved. https://www.globenewswire.com/news-release/2020/12/18/2148121/0/en/Novartis-receives-complete-response-letter-from-U-S-FDA-for-inclisiran.html My point is - Novartis wants to be in the cardiac space. They could be looking at Meso's stellar CHF results, imo. Inclisiran would be a first line drug for lowering LDL-C while Revascor could be a drug for preventing heart attacks and/or strokes. Could Novartis shoot for a end-to-end solution in cardiac disease? By the way, shame on SI for getting the primary endpoints upside down on the CHF P3 trial.
BTW, if not Novartis, there should be other companies interested in REVASCOR.
2. The COVID ARDS trial: This was not a shock to me. Why? When I saw that the recruitment was slow, I suspected that time was working AGAINST Mesoblast. The longer it dragged out, the stronger the chance was for other treatments to work and start clouding the results for Remestemcel-L. How come they could not recruit 300 patients within, say 2 to 3 months is beyond my comprehension. That during a pandemic of epic proportions. What were the logistical issues in recruitment? If SI being in Australia instead of being in the US is hampering things, then he needs to move his ass out here.
I believe Remestemcel-L was dealt a very bad deal in the trial design. But I also believe that Remestemcel-L can hit a home run in the ARDS space. Just make sure to design the trial sensibly. Novartis will ensure that. Move over, SI. Remestemcel-L is in better hands. Also this from the PR: "Novartis entered into an exclusive worldwide license and collaboration agreement with Mesoblast to develop, commercialize and manufacture Remestemcel-L for the treatment of acute respiratory distress syndrome (ARDS), including that associated with COVID-19." The agreement was for ARDS not just for COVID-19 induced ARDS. The key takeaway for me is that Novartis is very confident and believes in Remestemcel-L for treating ARDS. They did not wait for the COVID-19 induced ARDS. I can bet that they knew the trial design in the COVID ARDS trial was effed and knew what was going to happen to the primary end points. Mark these words from John Tsai, M.D., Head of Global Drug Development and Chief Medical Officer for Novartis "......Remestemcel-L has the potential to be the first treatment for the most critically ill ARDS patients". He does NOTmention COVID-19 ARDS.
3. And EFF the FDA for saying no to Ryoncil for aGvHD.
PS: My post is not intended as investment advice. Please make your own investment decisions after due diligence.
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