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Strategies & Market Trends : Rande Is . . . HOME -- Ignore unavailable to you. Want to Upgrade?

To: Rande Is who wrote (10148)	7/28/1999 8:11:00 PM
From: DanWebzster	Respond to of 57584

Here's an FDA approval play I've been watching for a while. The approval date should be in early September. More specifically, its a Re-submission play. My last FDA resubmission play, DRMD, was my second most profitable trade of the year. TXB had its NOVASTAN submission disapproved by FDA in May '98 not because of the drugs efficacy, but because the control group was not screened using the gold standard diagnostic test for the condition in question. That is, there may have been false positives in the control group. In any case, this drug has been approved and used safely in Japan for a number years. This is important because FDA has recently (12-13 months) begun to allow data from other countries to be used as part of the application process. One other thing, SKB has partnered with TXB and helped with the re-submission. I am long this this issue.