Bruno:  You were gone for a while-hurricane!

 

I sold half a couple weeks ago (reported in the general dow thread) and the rest this morning.  extreme trouble getting on the board-this may not go through?

 

The results showed 20% survival and the success of the study needed to be a 22% increase in survival.  This means the interim data were good, but did not meet the statistical threshold for approval off the interim data that was previously posted as the agreed to goal between FDA and DNDN.

 

Therefore I believe the study will go to its conclusion in 2009 and I have severe doubts the FDA will approve this based on the current results.  DNDN can submit and try, but based on what happened last year, I doubt they will let this through.

 

You can hold and hope the FDA says good enough?  They don't have a history of doing that based on the powerful dude in the FDA oncology division (Dr. Pazdur).  If the FDA were working properly they WOULD let this through!

 

Its a very risky bet upon release of these survival data.  I recommend listening to the DNDN 9:00AM presentation hosted by Dr. Gold (DNDN CEO) this morning.

 

I am out for now (better or worse)

 

JMO

 

Kutz