>>Name 3 cases where a company has published a 483, redacted or otherwise.<<
1.Google FDA Form 483. Among the tens of thouasand of hits there will be enough Form 483's for you to read to your heart's content. The vaccine operations of Sanofi Aventis and Wyeth tend to be best sellers.
2 >>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.<<
First, should DNDN really care about offending the likes of Pazdur and his trolls from those in the FDA who would have respected the recommendation of the AC? The appeals process and the Federal Admin Code are there for a reason to assure a fair process and eliminate procedural irregularities. If an applicant isn't prepared to defend its basic rights, no one should complain if those rights get trampled. This issue is independent of the Form 483 issue which is a question of inspection facts, not basic procedural rights.
3. >>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.<<
Go back to the FDA /NCI February workshop where the new paradigm was discussed at length.Patients who progress during the first three months after randomization would be censured; only those who progress later would be counted.
4. Factual evidence not emotion points to the Form 483 and the February FDA preapproval inspection not being disclosed until after the receipt of the CRL and to three directors selling shares who presumably were aware of the pre-approval inspection and its results.
5. >>I'll bet that in a year Gold is still in charge and has not been indicted. << I never said that he would be indicted, although if a Court finds that he improperly profited from the use of insider information, it would be nice to see him disgorge any such profits. Actually, something like 99% of 10-b-5 actions that successfully reach the discovery phase are settled, so managers have many ways to avoid exposure. Here many on the DNDN BOD seem to have even ignored the language of the annual 10K that they signed and sent to the SEC. In the absence of a strong BOD, execs can have a free hand to do what they like. Unfortunately, lawsuits are effectively one of the few tools left to shareholders to correct the situation.
