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Biotech / Medical : ABTI Alpha-Beta Technology
ABTI 0.0002000.0%Nov 7 9:30 AM EST
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To: biowa who wrote (145)6/16/1997 10:44:00 AM
From: Rosemary   of 572
 
Biowa,

Mr. Spiros Jamas has responded to my inquiry, he sent it airborne express. He obviously wants the word out. I will paraphrase:

"...First of all, I would like to stress that there are no problems that we are not disclosing.

The database for our Phase III clinical trial contains hundreds of thousands of data points. The accuracy and completeness of the database is paramount for successful filing with the FDA. As such, the database is checked both manually and electronically for errors, missing data and clarification. Numerous questions are generated, and sent back to the hospitals for resolutions. This process is repeated until the database has achieved a high level of quality and completeness.

At the beginning of the week it became clear to us that we would require 2-3 weeks more to complete the data verification process to our satisfaction. Rather that compromise quality we chose to allow the additional time which we announced immediately.

I would also like to explain the role of the expert panel (Adjudication Panel) that will review the infection data in our trial. This was agreed to and endorsed by the FDA in January 1995 before we started the study".

The letter goes on to explain how they had to reschedule the panel because of the delay in getting all the data together.

Now we all can be at rest over the postponement. I guess the word is out because the price of the stock is holding very well. So onward and upward.
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