To: VLAD who wrote (6629 ) 4/7/1998 9:53:00 PM From: Anaxagoras Read Replies (2) | Respond to of 23519
****SERIOUS, SOUR, DOUR, NON-HAPPY HOUR, GRIM FACED, HEAVY DUTY NON-CHAT STUFF**** <<Vivus had it's TV commercial pulled off the air by the FDA (correct?).>> Oui. Check out this from the 10-K out about a week ago: <<...the Company launched its first domestic direct-to-consumer advertising campaign in January 1998. This campaign includes major television, newspaper and magazine placements. In February 1998, the FDA notified the Company that it objected to, among other things, the prominence and balance of side effect information relative to efficacy information in certain written materials and the Company's television advertisements. The Company is no longer utilizing the prior written materials and has modified its written materials in response to the FDA's comments. If the FDA does not believe the modified written materials respond to its concerns then further modifications would be required resulting in additional cost and delay prior to the Company resuming its written advertising. The Company has ceased running its television advertisements and requested a meeting with the FDA to discuss necessary changes to the Company's television advertisements. If the Company and the FDA cannot reach a prompt resolution regarding the necessary changes to the Company's television advertisements, this could result in additional cost and delay, and may prevent broadcast advertising on major networks. Cost and delay associated with the FDA's objections to the Company's direct-to-consumer advertising materials could have a negative effect upon the Company's domestic sales and marketing efforts.>> Anaxagoras PS- If you wouldn't mind, put me down for ($.08) so that Colby and I aren't sharing the square at ($.07); I'll go with my fully diluted number. :-