Replies to post #4481 on Dendreon Corp fka DNDNQ

[iwfal]

1. The true status of the CMC issues can be easiiy cleared up by publishing a redacted form 483 to remove "proprietary" items

Name 3 cases where a company has published a 483, redacted or otherwise. Given that there are thousands every year... .

DNDN could have appealed the FDA CRL with little impact on the much delayed schedule caused by agreeing so rapidly to await the interim survival results and even taken the FDA to court for procedural irregularities under Federal Administrative law.

What is the general history of companies that take the FDA to court? What percentage are successful? Vs how many build up exceedingly bad blood at the FDA? Given these odds this is not evidence of a meaningful 483.

Again an unrealistic post.

Under the new paradigm for clinical trials of cancer vaccines and immunotherapies, an initial ramp up period for an immune reaction to become effective(suggested at three months) is allowed, which would have made 9901TTP statistically significant, but was not allowed in 9901(retrospective and long since passed) and would not have helped 9902a.

Really? Point me to an SPA with that as the primary endpoint. And even if this were an accepted endpoint there is NO WAY to do it for 9902b patients - who stop being checked after they progress relative to the measurement made at randomization.

one does not have to be bitter to be disgusted with DNDN's management and to want the very best therapy available to cancer patients as quickly as possible

No. And I am not defending Dendreon management generally - just on this specific issue. I have openly said they have significant problems and have said so for years. But you are doing a flip - and as my above points show, one that looks a lot more like it is emotionally driven than factual.

I'll offer you the same bet that I gave Dew - I'll bet that in a year Gold is still in charge and has not been indicted for any SEC violations. Do I wish that companies were more forthcoming about things like SPAs, 483s, ... ? Yes, but the reality is that 99% aren't and they are not successfully indicted.