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Re: eagle-eye post# 5434

Monday, 03/03/2008 12:40:08 PM

Monday, March 03, 2008 12:40:08 PM

Post# of 12660
eagleeye:

Since the method of allocating an interim alpha is apparently locked into a trial protocol long before an interim for both DNDN and its only realistic "competitor", CEGE (whose low O'Brien Fleming allocated alpha for Vital 1's interim has now been passed with the final look in 2H09), "competitive concerns" seem like thin gruel. At the risk of being overly naive, one would think that a CEO / MD would realize that that there is plenty of room in the AIPC "market" for both Provenge and GVAX, which also could be somewhat complementary in terms of patient benefit. A cynic might, of course, note that Gold withheld disclosing the fact that the FDA issued a Form 483 in its preapproval inspection while he sold $2.7 million in DNDN shares in April and any revelation of a conservative interim alpha might impact optimism while raising money, issuing management options, etc. Gold, of course, expressed surprise when the FDA issued a Complete Response Letter in May, before noting that DNDN had little contact with the FDA after the Provenge Advisory Committee meeting when FDA Guidance states that that period is the time that labeling discussions would be held. Caveat Emptor. JMHO.

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