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.
I stand corrected. There is a whole FDA folder of nothing but redacted 483s.
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.
That isn't reality and you know it. Just like the whistleblower laws do NOT prevent retaliation. A nice theory - but the only people who blow whistles are those who put morality above practicality or who are already on the outs. Not a wise idea to piss off the agency.
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.
Ok. Still not an accepted endpoint. Also note that the FDA is steering away from TTP in general - so going in and trying to modify the SPA, which at that point had survival as the primary endpoint with all the alpha, back to TTP, espcially a totally new paradigm of TTP, is completely unrealistic.
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.
So, essentially you are saying that they will learn nothing from this. So the point is... . Are you one of the lawyers on this (and so stand to gain a much higher percent than just the average joe blow shareholder?)?
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