I just finished watching the webcast (which I would recommend that all shareholders do) and I was going to post a few very important points that you have just covered in your excellent post.
1. SI has met with the FDA multiple times and said that it is clear that the FDAs primary objective for having a product approved is reduction of mortality. He went on to say that that this was a "dramatic" reduction in mortality that he believes will be taken seriously by the FDA and he would be meeting again with the FDA shortly.
2. It appears that the benefit of the therapy is reducing the significant damage the occurs to the heart as a result heart events leading to hospitalisation. In this respect it works very differently to other treatments. SI believes that Rex-L is uniquely equiped to reduce inflammation in CHF and induces a small vessel network that reduces the formation of scar tissue that is typically associated with such events.
In other words, it doesn't necessarily reduce the occurrence of CHF events, but it does reduce the damage caused by each event.
This could help explain why there was no difference in the primary endpoint, but a huge reduction in mortality. It also indicates why the target market is primarily those with stage 2 CHF. They stand to benefit the most as there would be more healthy heart tissue to preserve (prevent scarring). The study demonstrated that the stage 2 patients administered with Rex-L did not seem to progress to stage 3, where as those that did not receive treatment did.
Bottom line is that it works on the most important measure of all - reducing mortality rates.
Personally, I am very comfortable with my holding in MSB after listening to the webcast and, once again, would that all shareholders listen in as well.
This is my opinion only, and certainly not to be taken as financial advice as it's all gut feeling - In stark contrast to the negative sentiment and sharp drop in share price, looking at the magnitude of the mortality results, I would not be at all surprised if the FDA approves this. And given the way that the mechanisms reduce inflammation I am feeling better than ever about the likelihood of a positive ARDS result. Like I said, gut feeling only, but let's wait and see.
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