**from our good buddy overlook.
The following arguement has been presented to me as a case for non-approval. I do not have the knowledge to evaluate it. IV Board comments would be highly valued:
1. No placebo controlled cancer trial has ever had a drug or process approved in the manner with which DNDN is seeking approval.
2. An FDA edict from 1995 states that all clinical trials having to do with Survival must include the standard of care in one arm.
3. The FDA is very clear on clinical trials for drugs or processes that have survival as a primary endpoint. The DNDN trial (trials) did not have either: 1.) Patients that failed all other therapies or 2.) a trial which included the current standard of care plus placebo in the control arm .
4. DNDN changed the entry criteria for patients in the trial (trials). The original endpoint was designed to show Time to Progression in 2005. Midway through they changed the end point to Survival. DNDN sahould have started a new trial.
Please understand, I have been long DNDN for 4 years. I was very badly hurt in 2007. I have re-established a long stock position. I am just trying to not make the same mistake twice. I may want to hedge some of my position by buying puts. I hope this sincere inquiry is not mis-construed as a attempt to spread FUD.
Bashers and shorts lost a long time ago on this stock .. get over it ... yet they stick around getting more punishment .. figure they must like losing money.
Ignore feature works great .. so now buzz off