In case you missed this on the IV board, some interesting comments from a discussion with Greg Schiffman.
In speaking yesterday about the New Jersey facility, Dr. Gold used two words that left unclear his exact meaning.
Those words were "ramp-up" and "validate"
I spoke this morning with Mr. Schiffman. When asked for clarification as to the intended meanings, he took time to explain. I received permission to share these explanations publicly.
1. Throughout 2007, the plant was quite busy attending needs imposed by the 9902b Trial. But in November, the plant went back into a "maintenance mode" as work levels dropped off dramatically as a consequence of the completion of enrollment on 8/31/07.
2. It had been "validated" (by FDA inspectors) for Production in January 2007 (or earlier). (You perhaps recall that in the Fall of 2006 Jersey and others monitored unusually heavy activity at the plant—which a guard told jersey had something to do with an FDA inspection, as I now recall.)
3. Processing of patient's blood cells had been shifted from the Mayo Clinic and Seattle (and maybe elsewhere) to New Jersey at that inspection time or shortly after. This was done soon after the plant had been "validated." Gold told us yesterday that the plant in 2007 achieved a high level of activity—the most processing in any given period that the company had ever done. The meaning of those words was simply that, with the plant available for use, the company had taken over all the processing just as the 9902b Trial was enrolling at its maximum rate. He was telling us that the plant performed very well and had demonstrated an ability to deal with volumes larger than the company ever had experienced before.
4. The now infamous CMC 483 inspection in January 2007 had nothing to do with this "validation." I understood him to say that those January 2007 additional inspections were something apart that in no way interfered with the production levels achieved throughout the year in 2007. Further, Dr, Gold was telling us that they also had in no way interfered with our existing prior "validation," IMO, when he stated that the plant is now (and has been) fully "validated" for Production. In other words, those words of his had nothing to do with the 483s.
5. But it is important here to discuss—and this is me speaking now—what is going on at the plant right now in March 2008. It has been minimally occupied and in most businesses, would have been "shuttered" for a few months to save money. This, of course, has not been done, and, in fact, could not be done without costing the company as much as a year or more to re-start and re-validate it. This is an important point. I have written before that it is like restarting an oil refinery once it has been mothballed. So Gold and Schiffman were telling us yesterday that the plant is being maintained "at the ready" despite that this is a costly proposition. It simply would be more costly in delay when the company could least afford delay, if they had retreated to the production elsewhere while the New Jersey plant lay fallow. So the plant remains fully "validated" to avoid re-validation.
Why are they telling us this? Because they wished to convey that we remain "at the ready" awaiting the Interim and, hopefully, an opportunity to swing into production a few mnonths later. It bespeaks confidence in the near-term outcomes in my opnion.
________
As to the reference to "ramp-up" of the plant later this year, it apparently was a reference to the work required on the new Provenge Trials to be launched this spring, and was not a reference to expanding plant capacity except for the additions of employees necessary to handle the new Trials.
News 
Market Data 
Discover 
