Anthony @ Equity Investigations, Dear Anthony, Message Board

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Strategies & Market Trends : Anthony @ Equity Investigations, Dear Anthony,

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To: Yak-attack who wrote (45789)	10/26/1999 3:37:00 PM
From: Anthony@Pacific	Read Replies (3) of 122087

SNRS<------------------ACTUAL FDA Comments on last application! No reason to believe anything will be different except that they can sell more stocdk again Interesting reading in the Sunrise Technologies FDA notes (attached below), 32 32 bioresearch monitoring, please contact Charma Konnor who is the Director in the Division of Bioresearch Monitoring. That applies to all PMAs. Another item I would like to bring to the attention of the Panel concerns some of the complaints we have received about the sunrise PMA which we will consider this afternoon. FDA and Panel members received several complaints that Sunrise's clinical investigators held significant amounts of stocks, options or warrants in the company and that by virtue of these equity positions the data generated by these investigators was, therefore, biased. One of the faxes contains complaints about the design and execution of the study as well as the question of bias in the study. The issues raised by these complaints are not on the agenda for Panel consideration. FDA advisory panels were established to advise the agency on scientific and clinical issues that arise during the consideration of applications and other clinically related issues. They are not intended to deal with conflict of interest or data integrity issues. If we find that data in an application suffers from such infirmities that application may not be presented to the Panel until all such issues have been resolved 33 33 satisfactorily. In fact, when issues related to the integrity of the data are discovered appropriate action may be taken at any time prior to or after Panel review or at any time prior to or after FDA approval of the application. FDA is concerned about the integrity of the data or the design and conduct of the studies in all of our applications, and we have a very active and effective program to assure our decision making is based on accurate, complete and unbiased data and information. Our staff takes very seriously any allegations concerning these matters, and we will look into these allegations and take whatever actions are appropriate. However, our investigations are discussed in camera and not discussed with the public or with the informants from whom we have received information. Thank you, Mr. Chairman. DR. MC CULLEY: Thank you, Dr. Rosenthal. We will now begin deliberation on PMA P990010. We will begin with a 60-minute sponsor presentation, and again if each person who speaks for the first time will identify yourself and your position relative to the PMA? DR. KEZIRIAN: Good morning, ladies and gentlemen. Thank you very much for allowing me to appear before you and thanks to the FDA staff for a lot of cooperation and <<Sunrise Tech FDA.pdf>>

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