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Biotech / Medical : VISX -- Ignore unavailable to you. Want to Upgrade?


To: Gullapalli who wrote (1249)8/3/1999 9:36:00 PM
From: Charlie Smith  Respond to of 1754
 
Gullapalli:

Here's why. All the stocks in LVC group were hit today.

Summit Warned About Sterility Problems With Eye Surgery Device

Waltham, Massachusetts, Aug. 3 (Bloomberg) -- Summit Technology Inc., which makes equipment for vision correction surgery, didn't ensure the tiny steel blades used in the company's microkeratome vision correction system were properly sterilized, the U.S. Food and Drug Administration warned.

The warning letter followed a May inspection of Summit's facility in Cork, Ireland, and said that the company had no sterilization specifications for the blades.

The lack of sterilization standards raised such concerns about the company's ability to guarantee the sterility of the blades that the FDA said it may halt product imports until Summit corrects the problems.

The lack of documentation ''raises concerns as to whether the microkeratome blades distributed by your firm were adequately sterilized,'' the letter said.

The letter was dated July 14, 1999 and was released today through the FDA's Freedom of Information office. The company didn't return calls seeking comment.

Summit's microkeratomes are manufactured by an unnamed third party in Germany, according to company filing with the Securities and Exchange Commission. Those products are then tested by Summit's Ireland plant.

The inspection also found that the sealed packaging of the blades had never been tested, according to the letter.

Summit shares fell 1 15/16 to 21 3/16 in late trading.

The FDA sends hundreds of warning letters to companies each year, and only a small minority result in any significant agency action. However, the letters can be the last notice before the FDA takes steps such as delaying approvals of new products or pursuing civil fines.

Aug/03/1999 15:47



To: Gullapalli who wrote (1249)8/3/1999 10:48:00 PM
From: Walter in HK  Read Replies (1) | Respond to of 1754
 
All LVCs except TLCV dropped. BEAM the most %

The reason was not the FDA letter of the previous post, I don't think.

Don't know the reason. Sudden disenchantment, but why ?



To: Gullapalli who wrote (1249)8/4/1999 10:09:00 AM
From: Angler  Read Replies (1) | Respond to of 1754
 
Gullapalli:

Remember that all of us are into many other issues. The laser stocks are, perhaps, only 20% of a portfolio which is not doing well?
With Greenspan standing by with an axe and the critical employment report coming out Friday, folks are profit "saving" maybe not profit taking. Institutions are registering profits. My take.
The key to this attitude is the market opening "UP" in the morning but always fading at the end and in a declining market. Speculators are not waiting to get out. Along with them some investors with long profits are not going to watch forever without getting the idea. IMO
I know one trader type who has been in and out of VISX 3X since I bought and held. He claims he's making more profit than we do. His current plan is to get back into VISX in the 80s - maybe less. The last time he bought, the price was under 50 some 8 weeks ago.

Angler



To: Gullapalli who wrote (1249)8/4/1999 1:32:00 PM
From: gc  Read Replies (1) | Respond to of 1754
 
More sellers than buyers.