Oh, I knows his stuff very, very well and will probably work for...

Oh, I knows his stuff very, very well and will probably work for a Pharma or CRO/consultancy. Sometimes, the real world doesn't work the way the textbooks and standards document. The big budget Pharma's have the luxury of huge margins and massive blockbusters to fund their programs or cherry pick the best upcoming drugs from the little guys. They do this with mainly incremental gains in efficacy and play the regulatory game very well with questionable marginal/efficacy.

Here we have a pioneering company which is trying a whole lot of indications for their treatments off their own shareholders funds, not massive franchise revenues. Expecting them to understand the full MOA on all their indications is not possible at this time. But when we have an RCT showing gold standard efficacy and then nitpicking on the phase 2 study and its MOA or sub-analysis, it does get me going. Yes, no one knows exactly how the human body will respond to a completely new paradigm in CHF treatment. How many decades do we want to do and redo phase 2 trials to postulate more and more MOAs? Who will fund this? Who will innovate if we can't use common sense when we get a result like this? The real world (and even the FDA) says we cannot ignore secondary endpoints which reduce mortality rates over SOR irrespective of whether they were primary endpoints or not. It appears the some people prefer the Pharma machine to keep making small incremental gains with drug programs which have marginal efficacy and risk/benefit favour over highly promising therapeutics which may provide major leaps over SOR. They own the chess board and modify the rules as it suits them. So we don't need lectures on why we don't follow their rules when they become unhinged from real world outcomes and patient benefits. There currently a number of babies and U12 children who have died over recent months as a result of that unhinged logic. Hopefully we won't have a situation where we have CHF patients robbed of many years of their lives due to the same mindset over the coming years.

Rant over for the day. I'm getting a little unhinged myself after today's close but not close enough results.