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son: A thumbs-down from the FDA can mean that 12 years and tens of millions of dollars worth of work on a drug are on hold, or even out the window The merest hint that the FDA may have serious questions can prompt Wall Street to flee the stock, as Antigenics learned when it was placed on clinical hold The FDA makes or breaks them That s their livelihood, said David Perlin So people working for a drug company are going to be very, very careful about what they say in public Because of the FDA s impact, if you get a 301-area code phone call that s the area code for Rockville late on a Friday afternoon, it is always something you take with a certain amount of trepidation, said Boyd Clarke.

Do pharmaceutical executives really think that if they utter some criticism of the FDA in public, the agency s reviewers would retaliate by rejecting their drug It is not so much that there is a real fear that if you say something that is unpalatable, that there would be a retribution But the thought of that is resident enough in the base of your mind, one biotech executive explained (anonymously, of course) He compared the risk of talking about the FDA to the way a baseball player or manager would feel if asked to give his opinion of an umpire: You may have no reason to believe they ll shrink the strike zone, you may not have any evidence that they ever have, but the impact of tightened requirements is so damaging.

(b) Using Z(i, j ) , rewrite c ( x , y ) in terms of a single variable z = x y by replacing each x i y J by ~ ' ( ~ ,to obtain the representation d(z). j) (c) Show that the set of code polynomials d(z) so obtained is cyclic. 10.4 For each of the following ( M , pairs, draw the cross interleaver and the corresponding deinD) terleaver. Also, for the sequence xo,x i , x2, . . . ,,determine the interleaved output sequence.

People on both sides describe a relationship that can be capricious on the FDA s part and almost obsequious on the company s If they say, run Study X, and Study X is one of the stupidest ideas, said Hutt, the patrician lawyer, I advise the client to do it anyway If a reviewer asks for something, don t argue that you have already provided it; don t complain that the FDA told you last year that you would not need to have the data Across the divide, from his vantage point as a one-time FDA reviewer, Tom Garvey can see how an executive would jump at his slightest command For instance, Garvey might request an analysis of liver abnormalities in three of a company s studies [The company] would say, I ll have it to you later this afternoon Whatever you say, sir And they would have it.

2) Create a class R S d e c which implements a Reed- 4) After you have tested and debugged your decoder, reSolomon decoder for primitive, narrow-sense codes. Use place the Berlekamp-Massey algorithm with the Euclidean the Berlekamp-Massey algorithm to find A(x), followed by algorithm to determine A(x) and Q ( x ) . Test the resulting

Common Gateway Interface, the rst interface for server-side Web scripting. Server-side scripts impose more load on the server, but generally don t in uence the client even output to the client is optional; the client may have no idea that the server is running a script. Perl, Python, PHP, and Java are all examples of server-side scripting languages. The script typically resides only on the server, but is called by code in the HTML document. Although server-side scripts cannot read or write to the client s le system, they usually have some access to the server s le system. As such, it is important that the system administrator take appropriate measures to secure server-side scripts and limit their access. Unless you are a system administrator on the Web server you use to deploy your content, your ability to use server-side scripts is probably limited. Your ISP or system administrator has policies that allow or disallow server-side scripting in various languages and performing various tasks. If you intend to use server-side scripts, you should check with your ISP or system administrator to determine what resources are available to you. This chapter deals with client-side scripting.

What did it feel like, to have all that power Like nothing, Garvey said He just wanted to know about those liver abnormalities..

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Let M be the module generated by R-linear combinations of f l , f2, and f3. We could denote this as M = (fl, f2, f3). This set is minimal, in the sense that (fj, f j ) does not generate M . However, they are linearly dependent, since

(4.51a)