Dendreon Corp fka DNDNQ

[rancherho]

http://www1.investorvillage.com/smbd.asp?mb=971&mn=187807&pt=msg&mid=4342354

Eagleye:

Gold's use of the word "validation" in relation to the NJ manufacturing plant was just more of the same meaningless spin. The issue was, and is, FDA approval of commercial production as a result of a successful FDA preapproval inspection. Schiffman previously acknowledged at the 3Q07 CC that the FDA will require a reinspection during any new review cycle. There was some suggestion that DNDN had made a new submission to the FDA recently, which may have been a corrective action plan, which has to be approved by the FDA before they will schedule any renspection. For example, DSCO's initial submission of a corrective action plan, reportedly of over 100,000 pages, was not accepted by the FDA.So, getting such a plan submitted for FDA review and hopeful approval is an important first step. The scope of any plan would obviously be a function of the number and nature of the discrepancies listed in the February 2007 Form 483.

It amazes me (finally) that after so many past outright misleading statements and omissions that investors put any faith in what Gold says. With all the discussion about "comparable power", increased events, etc. at the interim, one of the most important aspects is, of course, the allocated alpha. If DNDN stated clearly what that p value is, the many fine stat experts both here and on IV would be able to give a far better reading of the probabilities of success at the interim. Can anyone offer a reason why shareholders should not be given this info.

I truly hope that the FDA finally approves Provenge, but if and when that happens, it seems increasingly likely it would be in spite of Gold. JMHO.