Hmm, let me see, so this means that DNDN should have known in March that Provenge could not be approved until they fixed the issues raised and a 6 month clock would tick again! And to top it all the CEO and directors sold shares while being privy to this info. Even if this was an error and not deliberate, they are still liable I guess for negligence.
If this is a simple matter of procedural law well understood by the FDA and biotech companies, this class action suit will at the minimum result in a change of mgmt in DNDN.
Can anybody comment on any example where approval was granted post issuance of this 483 letter? Looking for indication of minimum time required.
Seriously speaking, following DNDN has been a fantastic education so far.
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