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To: RWReeves who wrote (593)8/1/2000 4:45:02 PM
From: Toni Wheeler  Respond to of 743
 
re: GNLB

Something is 'cooking' with Genelabs lately; today, particularly:

GNLB: GENELABS TECHNO
Time Last Change
15:58 3 7/8 + 7/16
Bid(Size) Ask(Size) Volume
  3.66(1) 3 7/8(30) 347,200
Open High Low
3 7/16   3.97 3 3/8
#Trades Avg Size Last Size
476 729 800
52WkHi 52WkLo Last Tics
16 1/2 1 1/2 -+-+

GNLB - GENELABS TECHNOLOGIES
Exchange: Nasdaq NM
Delay: at least 15 minutes
Last Price: 3 7/8 at 15:58 EDT
Change: Up 7/16 (+12.73%)
High: 3 31/32 at 13:19 EDT
Low: 3 3/8
Open: 3 7/16
Previous Close: 3 7/16 on 7/31
Volume: 347,200
30-Day Avg. Volume: 393,000
Shares Outstanding: 40,795,000
Market Cap.: 158,080,625
52-Week High: 16 1/2
52-Week Low: 1 1/2
Beta: 0.44

Some nice DD has been posted on the Raging Bull GNLB board. It appears the company has filed with FDA proving that DHEA should not be classified as a 'dietary supplement' and requesting a ruling for their request:

<<<SUMMARY: The Food and Drug Administration (“FDA”) has received information to suggest that products containing dehydroepiandrosterone (“DHEA”) may not legally be marketed as “dietary supplements” under the Federal Food, Drug, and Cosmetic Act (“FFDCA” or “the Act”). All interested persons are hereby notified of the process FDA will use to determine whether DHEA-containing products may legally be marketed as “dietary supplements” under the Act. ...

<<<...FDA has determined that the evidence submitted by Genelabs establishes aprima facie case that DHEA is excluded from the definition of “dietary supplement” under Section 201 (ff)(3)(B)(ii) of the Act. ...>>>

The speculated timeframe is this week for the decision. If the ruling is in their favor, I would assume the way would be cleared for fast-track approval of their GL701 product for SLE treatment.

If more info is desired, check out the RB thread for some compelling articles and opinions. I believe Yahoo! also has some astute posters.

My best,
T.