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Biotech / Medical : PFE (Pfizer) How high will it go? -- Ignore unavailable to you. Want to Upgrade?


To: Hunter Vann who wrote (3583)6/19/1998 3:18:00 PM
From: Nemer  Respond to of 9523
 
Hunter:

this appears to be the reason for the 4+ dollar fall

biz.yahoo.com

Regards ---- Nemer



To: Hunter Vann who wrote (3583)6/19/1998 3:18:00 PM
From: Flair  Read Replies (1) | Respond to of 9523
 
Hunter & all, " Pfizer Receives Non-Approvable Letter
From FDA for the Antipsychotic Zeldox"

Friday June 19, 2:45 pm Eastern Time

NEW YORK, June 19 /PRNewswire/ -- Pfizer Inc (NYSE: PFE - news) said today it has received a
non-approvable letter from the U.S. Food and Drug Administration for its novel antipsychotic Zeldox
(ziprasidone Hcl).

Pfizer said it is planning to meet with the FDA to discuss the issues raised by the agency, including the possible
submission of additional data, as suggested by the FDA.

''We are obviously disappointed at this development, but remain confident of the safety and efficacy of Zeldox,''
said John F. Niblack, Ph.D., executive vice president of Pfizer Inc and head of Research and Development. ''We
remain committed to making every effort to bring this medicine to patients in the U.S. and around the world.

''We believe that the additional studies and analyses suggested by the FDA can be undertaken in a relatively
short period, and that we will be able to advance the application accordingly,'' said Dr. Niblack.