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Biotech / Medical : Zonagen (zona) - good buy? -- Ignore unavailable to you. Want to Upgrade?


To: Linda Kaplan who wrote (3824)5/3/1998 2:10:00 PM
From: Hank  Respond to of 7041
 
I don't think the FDA will be fooled by anything or be pressured to do anything other than what they deem correct. If SGP can't get a filing done by the end of June, something is gravely wrong IMHO. Remember that the FDA has to approve the filing through a review before they can file. It's not like submitting a job application. The FDA has complete control over what gets filed and what doesn't. If they can't get the FDA to allow them to file by the end of June, then it will be apparent that even the most diligent massaging of the data is not good enough.