Deny and Delay

Am I happy about the FDA's response? Absolutely NOT!

Was it unexpected? Not really.

After two decades of biotech investing--and yes, I'm still at it because I have made money at it--this sort of deny-and-delay approach by the agency is what I have come to expect. In fact, in my dozens of biotech investments I am hard pressed to think of one that sailed through the process other than Illumina, and they're an equipment maker.

People at the agency have FAR less to lose in denying a good drug than in approving a drug to later find out that it harms people; hence, the maddeningly slow and difficult approval process. Some changes are being made, but not enough and not quickly enough.

In my opinion, with Shoulson, Tanzi, Masters and others in our corner the problem has NOT been a lack of expertise at Prana--it's been the FDA.

Do I intend to sell my shares--NO. This is an investment on which I still expect to make money. But I will be watching and listening to management's explanation and their plans for the future. JMHO, of course.