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


To: technetx who wrote (38)3/18/1998 4:13:00 AM
From: Thomas Kirwin  Respond to of 422
 
Building Upon Core Technology

Technetx,

The market reaction was not all that bad as BLUD closed at 9 7/8 just 1/8th or -1.25% off its recent high of $10.00 on light volume of 35,300 shares.

This agreement with IBG Systems Limited only validates Immucor's conviction that the ABS2000 will be approved and drive the company's growth for the foreseeable future. It is comforting to know that this company has a vision and is willing to take the necessary steps ensuring success.

<<Edward L. Gallup, President of Immucor, Inc. commented, "This agreement expands our corporate vision to become the world leader in blood bank automation by offering a line of automated and semi-automated products for all segments of the U.S. market. These products, along with our flagship product, the ABS2000 (Pending 510(k), not available for sale in the U.S.) and our high volume microtitration plate processing DIAS PLUS system, allow Immucor to offer instrumentation tailored to meet the needs of all clinical laboratory market segments.">>

Immucor is building upon its core technology in the blood market. This strategic alliance may be the final step of securing its market or the necessary technology before approval of the ABS2000.

Regards,

Tom



To: technetx who wrote (38)3/18/1998 12:26:00 PM
From: Thomas Kirwin  Respond to of 422
 
ABS2000 Status Report

Technetx,

IMHO Immucor management possesses knowledge regarding the status of their golden egg the ABS2000. The FDA has a 510(k) Status Request Program in place that allows the submitter to request a status every 30 days. Of course this information is not to be publicly disclosed as required by the FDA.

Here is an excerpt from the FDA web site regarding this process.

510(k) Status Request Program

Applicants may request information on their 510(k) review status 90 days after the initial log-in date of the 510(k). Thereafter, the applicant may request status reports every 30 days following the initial status request. To obtain a 510(k) status report, the applicant should complete a status request form and fax or mail it to DSMA. Within 3 working days after a status request is received, DSMA will send the applicant a fax or letter that includes:

The branch to which the 510(k) is assigned;
The last action, and date of action, that ODE has taken regarding the 510(k);
The position of the 510(k) in the reviewer's queue; and
The average review time for the division or branch.

Regards,

Tom