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first one According to a formula understood only by statisticians and the FDA, 214 of the 650 patients in the first trial would have to show signs of a recurrence of their cancer, including patients getting Oncophage as well as those getting a conventional treatment like chemotherapy A sample that size would allow a meaningful comparison of the rate of recurrence among Oncophage versus non-Oncophage patients If the ones with Oncophage had a significantly lower rate, then that would be the time to go back to the FDA, show off the results, and ask if this was strong enough proof of the vaccine s effectiveness to cut short the second trial and file for approval Antigenics expected to have the data by winter Before the results are out, it would be very unproductive to have this kind of discussion That s a hard sale.

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Solution Owner Although all deliverables have multiple customers, solution owners are in effect the ultimate customer of the deliverable They are the people who are given primary responsibility for serving customers interests On internal projects, they are the senior executives who fund the project On external projects, they are the most senior executives who have responsibility for making sure that the customer organization receives what it wants Project Sponsor The senior executives who serve as guardian angels of the project within the organization are the project sponsors By virtue of their senior position, they have power that they can use to support the project effort For example, if a project team is having dif culty obtaining resources from the design shop, the project sponsor can talk to its head to see if the needed resources can be released quickly.

We don t want to force them to fix into a position they couldn t reverse later on, Armen explained Besides, he sensed a change in attitude at the FDA more of an insistence on going by the book tied in with the staff transfer However, the second trial, if it ran its full course, would cost the company $15 to $20 million and delay things an extra year and a half, to mid-2006 or even later As it turned out, once Gupta submitted the briefing material, the FDA wanted some additional information, and the meeting had to be put off two months until late July (Armen was right on the money in one of his predictions: the FDA did, indeed, ask for a third radiologist to assess trial results, as a tie-breaker.

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) In addition, the agency requested yet more background on the assays that Antigenics would be using to test the drug s potency; that was another 300-page submission On top of all that, virtually the entire FDA review staff changed yet again Even Phil Noguchi transferred to a different part of the agency So now about ten people from Antigenics regulatory and clinical staff were spending an hour or two per week on the phone and e-mail trying to bring the newcomers up to date, plus sending copies of material they had already submitted Armen guessed it would take the new FDA people a few months to catch up It was a heck of a maiden voyage for a company trying to cure cancer To be fair, it was also far from the norm.

slimmer and slimmer. 10. z (2Z i)/( iZ 2) by (3) in Sec. 17.3 12. i are fixed points, and straight lines are mapped onto circles (or straight lines). From this the assertion follows. (Alternatively, it also follows very simply by setting x 0 and calculating w .) 14. Apply w z 2.

FDA staff have been gracious enough to admit, Armen told me with a wry smile, that this has not been an optimal way to deal with our situation At least the 90-minute July meeting went well, according to Armen in fact, the agency even asked Antigenics whether its method of electronic data collection could be used as an oncology standard Then it was on to the next step..

LIMS, and it should be possible to tailor the access to functionality/commands and data for each user: r the user must log into the system in a secure way by using a user ID and a password, token, or biometric input that is unique to that user r users should have differentiated access to commands/functionality according to their needs and the types of jobs or roles that they have in the organization r users should have differentiated access to which data they are allowed to see, use, change, and maintain 18.27.2 Referential Integrity