now J+J got whacked even though again the drug is approved in the EU-soon you will have to go across the pond to get treatment!

 

This is why it is becoming almost foolish to play FDA decisions on drugs. You used to have fighting chance (risk vs big gain) Now:  They convene advisory committees and instead of following the supposed expert testimony, they use it to provide political cover, ignore them, and reject anyway. They then hide behind proprietary concerns that unapproved drugs have for their companies and as an investor you can't fairly calculate the odds for success/failure. They aren't evaluating the science and the drugs capability-they are evaluating their process on how to ensure their butts are covered!  Easy to see "if I approve little or nothing and create road blocks, I then can not be attacked later.  its an acceptance of what this process is-not ever for sure and risk vs benefit.   They take risk out of the equation and patients miss any benefit!

 

I don't want bad drugs on the market but the pattern is clear  This stymies the entire biotech world in the US.  Bushes FDA leadership must be purged or they will destroy one good industry America has left!  This agency track record is like every other federal agency now-dismal.  This is what happens when the leadership in each agency is only beholden to its ultimate leader and not to actually doing a job.

 

Invest in drug mergers, buyouts, data reporting etc, but investing in FDA drug decisions is torture currently-don't do it unless you are married to the particular stock!  I can't barely figure it out and I have been doing it for 10 years.

 

JMO

 

Kutz