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Biotech / Medical : Elan Corporation, plc (ELN) -- Ignore unavailable to you. Want to Upgrade?


To: scaram(o)uche who wrote (3261)9/30/2002 11:58:30 AM
From: Findit  Respond to of 10345
 
Rick thanks for setting the SEC straight. I am sure ELN will be free soon. LOL

Jim



To: scaram(o)uche who wrote (3261)9/30/2002 11:59:49 AM
From: Qualified Opinion  Read Replies (1) | Respond to of 10345
 
<Dear S.E.C.:>

I can't find a problem with the risk-sharing arrangements except for earlier disclosure.



To: scaram(o)uche who wrote (3261)9/30/2002 12:04:37 PM
From: aknahow  Respond to of 10345
 
FWIW I agree with your conclusion. The S.E.C. should get on with it and wrap this "investigation" up.

You have made the following point several times:

"
4. The company also inflated revenues with the JV scheme, but this was clearly described. For those of us who were looking at the deals
from the perspective of the small partner, it was "it should be illegal!". It wasn't. No harm, no foul."

Each individual deal may be understood but the combined effect is to allow a company to craft its per share earnings to meet or exceed targets and thus in certain phases of the stock market be rewarded with a large price premium, achieved by attracting investors willing to pay for earnings growth and the ability to meet projections.

One could say most big drug companies are guilty of the same thing. I have no argument to this. Baxter, at a recent earnings call told everyone that it did not care about meeting or beating earnings targets by a few cents. The next day it was punished but then recovered and has since move up and down based on other events.

So for me its not seeing the forest for the deals.

And there probably is no solution.



To: scaram(o)uche who wrote (3261)10/19/2002 12:14:22 PM
From: scaram(o)uche  Read Replies (2) | Respond to of 10345
 
Dermatol Surg 2002 Sep;28(9):817-21

Botulinum toxin type B for glabellar wrinkles: a prospective open-label response study.

Sadick NS, Faacs.

Department of Dermatology, Weill Medical College, Cornell University, New York, New York.

BACKGROUND: Botulinum toxin type B (BTX-B) is U.S. Food and Drug Administration (FDA)-approved for the treatment of cervical dystonia. There are no published studies investigating its efficacy for treatment of glabellar (frown) wrinkles; however, anecdotal reports of its efficacy are promising. OBJECTIVE: The current pilot study is an initial screening study to assess the safety and efficacy of a single, set dose of BTX-B in the treatment of glabellar (frown) lines and to document current clinical experience with BTX-B. METHODS: Thirty subjects (28 women, 2 men) were injected in six sites with 300 U per site for a total dose of 1800 U. RESULTS: At 2 and 4 weeks, patient and physician assessment scores showed an average score of 2 ("complete disappearance of wrinkles"). Three patients reported mild adverse events. CONCLUSION: Injections of BTX-B proved to be very efficacious, with rapid onset, with all patients responding within 3 days (mean 1.5 days). Adverse events were mild. The mean duration of effect with this low dose of BTX-B was 8 weeks. Since the duration may be dose related and minimal adverse events were observed at 1800 U, further studies are in progress to look at the duration of response resulting from higher doses of BTX-B in the treatment of glabellar wrinkles.

(and, for comparison, some studies posted previously.......)

J Cosmet Laser Ther 2002 Mar;4(1):15-8

Botulinum toxins types A and B for brow furrows: preliminary experiences with type B toxin dosing.

Lowe NJ, Yamauchi PS, Lask GP, Patnaik R, Moore D.

UCLA School of Medicine, Los Angeles, CA, USA; Clinical Research Specialists, Santa Monica, CA, USA.

BACKGROUND: Facial lines resulting from hyperactivity can be misleading manifestations of negative emotions, fatigue and stress. They may also contribute to a perception of facial aging. A well established treatment is botulinum toxin type A (BTX-A). Recently, botulinum toxin type B (BTX-B) has become available for the treatment of cervical dystonia. There has been little comparison on the efficacy of the two different types of botulinum toxins, nor is there information on appropriate dosing of BTX-B for facial muscles. OBJECTIVES: The purpose of this pilot study was to observe the effects of BTX-B in comparison to BTX-A, on patients with brow furrows assessing initial efficacy and duration of effect. METHODS: Patients were injected with BTX-B in two different dose conversions against BTX-A to the corrugator-procerus complex. Some patients received a conversion of 50 units of BTX-B (total of 1000 units) to one unit of BTX-A while others received a conversion of 100 units of BTX-B (total of 2000 units) to one unit of BTX-A. The patients treated with BTX-A received a total of 20 units. These patients were clinically assessed prior to treatment and 3 days, 1 week, 4 weeks, 12 weeks and 16 weeks after treatment. RESULTS: Both types of botulinum toxin were effective at improving glabellar frown lines. The onset of actions occurred slightly sooner (2-3 days) with BTX-B than with BTX-A (3-7 days). Duration of effect with BTX-A was at least 16 weeks. With 1000 units of BTX-B, dose duration was 6-8 weeks and with 2000 units of BTX-B, duration was 10-12 weeks. SUMMARY: Both types of botulinum toxin are effective at correcting deep glabellar furrows. At least with the doses used, BTX-B has a quicker onset of action and BTX-A has longer benefit for glabellar wrinkles. These data strongly suggest that further dose ranging studies of BTX-B are necessary and indicated in controlled double blind studies in a larger patient population.

Otolaryngol Head Neck Surg 2002 May;126(5):459-67

Botulinum toxin type B (MyoBloc) in the management of hyperkinetic facial lines.

Ramirez AL, Reeck J, Maas CS.

Division of Facial Plastic and Reconstructive Surgery, Department of Otolaryngology-Head and Neck Surgery, University of California, San Francisco, CA 94115, USA.

OBJECTIVE: Our goal was to evaluate the safety and efficacy of botulinum toxin type B (BTX-B) in the management of hyperfunctional facial lines. STUDY DESIGN AND SETTING: Twenty-four patients from an academic faculty practice were treated with 400 to 800 units BTX-B in the corrugator, orbicularis oculi, or frontalis. Patients were evaluated with the Wrinkle Improvement Score (WIS) and Rated Numeric Kinetic Line Scale (RNKLS) and questioned about side effects and pain. Evaluations were made at 1, 2, 4, 8, and 12 weeks. RESULTS: Onset of effect was within 72 hours. WIS and RNKLS for all sites were statistically better after treatment, with the effect lasting 8 weeks. In general, patients noted a moderate improvement (grade 2) on WIS and a 2-point improvement on RNKLS. Injection was more painful than that of BTX-A. There were no complications. CONCLUSION: BTX-B is a safe and effective technique to eliminate wrinkles. Further studies are needed to elucidate dosage and duration. SIGNIFICANCE: BTX-B is stable for prolonged periods of time, requires no preparation before use, and is antigenetically distinct from BTX-A.